ClinicalTrials.gg
Not yet recruitingNCT07654231RESOLVE-CKDUpdated Nov 4, 2026

REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial

A Phase 2 interventional study of Low-dose Colchicine at 0.5mg daily and Usual Care in Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function and Vascular Calcification, sponsored by University of Texas Southwestern Medical Center. Not yet recruiting at 1 site in United States. Open to participants aged 30 Years to 69 Years. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by University of Texas Southwestern Medical Center · Phase 2, Interventional, and Treatment

Updated Nov 4, 2026Start date movedPrimary completion moved+4 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
30 Years to 69 Years
Sex
All
01

Study summary

This pilot randomized, open-label, outcome blinded clinical trial is to evaluate the preliminary effects of low-dose Colchicine (LoDoCo) on coronary artery calcification (CAC) progression in adults with chronic kidney disease (CKD) and existing coronary artery calcification. Sixty participants will be randomized 1:1 to received LoDoCo plus usual care or usual care lone and followed for 24 months.

The primary objective is to evaluate the effect of LoDoCo on CAC progression measured by ECG-gates noncontrast cardiac computed tomography (CT). Exploratory outcomes include valvular calcification, bone mineral density, inflammatory, vascular, and miner-bone biomarkers, cognitive function, Alzheimer's disease biomarkers, peripheral arterial disease measures, kidney biomarkers, and participant-reported measures of treatment acceptability, adherence, and adverse effects.

Read the detailed description

The investigators will conduct a randomized, open-label, outcome-blinded, clinical trial in 60 adults with chronic kidney disease (CKD) and existing coronary artery calcification (CAC) Agatston scores of ≥100-1000. Participants will be randomized 1:1 to receive low-dose Colchicine (LoDoCo) plus usual care or usual care alone for 24 months.

The primary objective is to evaluate the effect of LoDoCo on CAC progression over 24 months. CAC will be assessed by ECG-gated noncontrast cardiac computed tomography (CT). Outcomes will include Agatston score and calcium volume. The study will estimate variance, baseline-to-follow-up correlations, and other parameters needed to inform future sample size, treatment duration, and endpoint selection.

Exploratory objectives include evaluating the effects of LoDoCo on aortic valve and mitral annular calcification, CT-derived vertebral bone mineral density, inflammatory biomarkers, vascular calcification biomarkers, and miner-bone metabolism biomarkers. Additional exploratory analyses will examine cognitive function, Alzheimer's disease biomarkers, peripheral arterial disease measures including ankle-brachial index (ABI) and toe-brachial index (TBI), and kidney outcomes including albumin-creatine ratio (uACR) and estimated glomerular filtration rate (eGFR).

Participant experience with LoDoCo will also be evaluated through assessment of treatment acceptability, adherence, adverse effects, and barriers and facilitators to study participation and retention.

Participants will be followed at baseline, 6 months, 12 months, 18 months, and 24 months for data collection. Participants assigned to the intervention group will undergo additional safety monitoring, including laboratory assessments, throughout the study period.

02

Conditions studied

  • Chronic Kidney Disease Mineral and Bone Disorder
  • Cognitive Function
  • Vascular Calcification
  • Coronary Artery Calcification
  • Mineral and Bone Disorder (CKD-MBD)
  • Peripheral Arterial Disease
  • Systemic Inflammation
  • Chronic Kidney Disease

Keywords

  • Chronic Kidney Disease
  • CVD
  • Colchicine
  • Cognitive function
  • Vascular calcification
03

In context

Chronic Kidney Disease-Mineral and Bone Disorder

73 studies on the registry are indexed under Chronic Kidney Disease-Mineral and Bone Disorder; 20 are open to participants now.

This study's planned enrollment of 60 is above the median of 54 across 34 interventional studies indexed under Chronic Kidney Disease-Mineral and Bone Disorder.

Browse Chronic Kidney Disease-Mineral and Bone Disorder studies →

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 1,010 studies on the registry; 199 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Nov 4, 2026. See what changed

Ages eligible
30 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Men and women aged 30-\<70 years of all race/ethnicity groups
  • Chronic kidney disease (CKD) stage 3 (estimated (eGFR) 30 to \<60 ml/min/1.73m2) or eGFR ≥60 and Urine albumin-to-creatinine ratio (uACR) ≥ 30 mg/g
  • Cardiac artery calcification (CAC) Agatston score ≥100-1000
  • Ability to provide .

Exclusion criteria

Exclusion Criteria:

  • Current Colchicine therapy
  • Hepatic disease
  • Established peripheral arterial disease (PAD) defined by self-report or ICD-10 codes
  • Congestive heart failure classified as (NYHA) Functional class III or IV
  • Uncontrolled atrial fibrillation with resting heart rate > 100 beats/min
  • Dementia defined by self-report or ICD-10 codes (F01-F03)
  • Alzheimer's disease defined by self-report or ICD-10 codes (G30)
  • Any clinically active diagnosed infection requiring systemic antimicrobial therapy, positive microbiologic evidence of infection, or infection-related hospitalization within 30 days prior to study enrollment.
  • , including the use of immunosuppressive medications
  • Current use of chemotherapy drugs or active cancer
  • Pregnancy/breastfeeding
  • Hospitalized within the past 6 months
  • Allergic/intolerance to colchicine
  • Use of P-glycoprotein (p-gp) inhibitor (such as Verapamil, Quinidine, Amiodarone, Ritonavir, Lopinavir/ritonavir, Saquinavir, Nelfinavir)
  • Use of strong cytochrome P450 3A4 () inhibitors (such as Ketoconazole, Itraconazole, Posaconazole, Voriconazole, Clarithromycin, Erythromycin)
  • (HIV) infection
  • Gout attack ≥ 1 time per year
  • Severe anemia ( \< 8 g/dl for women and \< 9 g/dl for men)
  • \<30 ml/min/1.73m2
  • White blood cell count (WBC) \<3.0 x10\^9/L
  • (AST) or alanine aminotransferase (ALT) > 3 x (ULN)
  • Total >2 x ULN
  • Glucose >300mg/dL
  • Uses recreational drugs
  • Participant in other conflict clinical trial
  • Unable to complete the study measurements
  • Unable to undergo to computed tomography (CT)
  • Unsafe to participate in this study per investigator's judgement
  • Unable to read and speak English or Spanish
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Low-Dose Colchicine (LoDoCo)

    Participants will receive low-dose Colchicine (LoDoCo) in addition to usual care.

    Drug: Low-dose Colchicine at 0.5mg daily · Other: Usual Care

  • Active comparator
    Usual Care

    Participants will receive usual care alone.

    Other: Usual Care

Interventions

  • Intervention group will receive LoDoCo (Colchicine 0.5mg), oral, once daily.

    Also known as: LoDoCo

  • OtherUsual Care

    Participants will receive usual care according to standard clinical practice and treating physician discretion.

06

What researchers measure

Primary outcomes

  1. Change in Coronary Artery Calcification Agatston Scores

    Agatston scores (Agatston units) will be measured by ECG-gated non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols. Coronary artery calcification will be quantified using the Coronary Artery Calcium (CAC) Agatston Score. Scores range from 0 Agatston units (no detectable coronary calcification), 1-99 Agatston units (mild calcification), 100-399 Agatston units (moderate calcification), and ≥400 Agatston units (severe calcification, high atherosclerotic burden). Higher scores indicate greater coronary artery calcification and are associated with worse outcomes.

    Time frame: Baseline, 12 months, 24 months

  2. Change in Coronary Artery Calcification Volume Scores

    Change in Coronary Artery Calcification volume (mm3) will be measured by ECG-gates non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols.

    Time frame: Baseline, 12 months, 24 months

Other outcomes

  1. Exploratory: Change in Aortic Valve Calcification Agatston Scores

    Agatston scores (Agatston units) will be measured by ECG-gated non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols. Aortic valve calcification will be quantified using the Agatston Scoring method applied to calcified lesions of the aortic valve. Scores range from 0 Agatston units (no detectable coronary calcification), 1-99 Agatston units (mild calcification), 100-399 Agatston units (moderate calcification), and ≥400 Agatston units (severe calcification, high atherosclerotic burden). Higher scores indicate greater coronary artery calcification and are associated with worse outcomes.

    Time frame: Baseline, 12 months, 24 months

  2. Exploratory: Change in Aortic Valve Calcification Volume Scores

    Change in Aortic Valve Calcification volume (mm3) will be measured by ECG-gated non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols.

    Time frame: Baseline, 12 months, 24 months

  3. Exploratory: Change in Mitral Annular Calcification Agatston Scores

    Agatston scores (Agatston units) will be measured by ECG-gated non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols. Mitral annular calcification will be quantified using the Agatston Scoring method applied to calcified lesions of the mitral valve annulus. Scores range from 0 Agatston units (no detectable coronary calcification), 1-99 Agatston units (mild calcification), 100-399 Agatston units (moderate calcification), and ≥400 Agatston units (severe calcification, high atherosclerotic burden). Higher scores indicate greater coronary artery calcification and are associated with worse outcomes.

    Time frame: Baseline, 12 months, 24 months

  4. Exploratory: Change in Mitral Annular Calcification Volume Scores

    Change in Mitral Annular Calcification volume (mm3) will be measured by ECG-gates non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols.

    Time frame: Baseline, 12 months, 24 months

  5. Exploratory: Change in Vertebral Bone Mineral Density (BMD)

    Change in vertebral BMD (mg/cm³) will be measured from ECG-gated non-contrast computer tomography (CT) using validated CT-based densitometry methods. BMD will be quantified within the vertebral bodies. Vertebral MBD values range from \<80mg/cm³ (very low), 80-120mg/cm³ (low), and \>120 mg/cm³ (normal). Lower TBI values are associated with worse outcomes.

    Time frame: Baseline, 12 months, 24 months

  6. Exploratory: Change in C-Reactive Protein (CRP) Levels

    Circulating CRP (mg/L) will be measured using standard clinical laboratory assays.

    Time frame: Baseline, 12 months, 24 months

  7. Exploratory: Change in Interleukin-1 beta (IL-1β) Levels

    Circulating IL-1β levels (pg/mL) will be measured using standard clinical laboratory assays.

    Time frame: Baseline, 12 months, 24 months

  8. Exploratory: Change in Interleukin-6 (IL-6) Levels

    Circulating IL-6 levels (pg/mL) will be measured using standard clinical laboratory assays.

    Time frame: Baseline, 12 months, 18 months

  9. Exploratory: Change in Interleukin-18 (IL-18) Levels

    Circulating IL-18 levels (pg/mL) will be measured using standard clinical laboratory assays.

    Time frame: Baseline, 12 months, 24 months

  10. Exploratory: Change in Tumor Necrosis Factor alpha

    Circulating TNF-a levels (pg/mL) will be measured using standard clinical laboratory assays.

    Time frame: Baseline, 12 months, 24 months

  11. Exploratory: Change in Interleukin-17 (IL-17) Levels

    Circulating IL-17 levels (pg/mL) will be measured using standard clinical laboratory assays.

    Time frame: Baseline, 12 months, 24 months

  12. Exploratory: Change in Monocyte Chemoattractant Protein-1 (MCP-1) levels

    Circulating MCP-1 levels (pg/mL) will be measured using standard clinical laboratory assays.

    Time frame: Baseline, 12 months, 24 months

  13. Exploratory: Change in Serum Klotho Levels

    Circulating klotho levels (pg/mL) will be measured using standard clinical laboratory assays.

    Time frame: Baseline, 12 months, 24 months

  14. Exploratory: Change in Fetuin A Levels

    Circulating fetuin A levels (ng/mL) will be measured using standard clinical laboratory assays.

    Time frame: Baseline, 12 months, 24 months

  15. Exploratory: Change in Osteopontin Levels

    Circulating osteopontin levels (ng/mL) will be measured using standard clinical laboratory assays.

    Time frame: Baseline, 12 months, 24 months

  16. Exploratory: Change in Bone Morphogenetic Protein-2 (BMP-2) Levels

    Circulating BMP-2 levels (ng/mL) will be measured using standard clinical laboratory assays.

    Time frame: Baseline, 12 months, 24 months

  17. Exploratory: Change in Bone Morphogenetic Protein-4 (BMP-4) Levels

    Circulating BMP-4 levels (ng/mL) will be measured using standard clinical laboratory assays.

    Time frame: Baseline, 12 months, 24 months

  18. Exploratory: Change in Bone Morphogenetic Protein-7 (BMP-7) Levels

    Circulating BMP-7 levels (ng/mL) will be measured using standard clinical laboratory assays.

    Time frame: Baseline, 12 months, 24 months

  19. Exploratory: Change in Serum Phosphate levels

    Circulating serum phosphate levels (mg/dL) will be measured using standard clinical laboratory assays.

    Time frame: Baseline, 12 months, 24 months

  20. Exploratory: Change in Serum Calcium Levels

    Circulating serum calcium levels (mg/dL) will be measured using standard clinical laboratory assays.

    Time frame: Baseline, 12 months, 24 months

  21. Exploratory: Change in Parathyroid Hormone (PTH) levels

    Circulating PTH levels (pg/mL) will be measured using standard clinical laboratory assays.

    Time frame: Baseline, 12 months, 24 months

  22. Exploratory: Change in Bone-Specific Alkaline Phosphatase (BSAP) Levels

    Circulating serum BSAP levels (ug/L) will be measured using standard clinical laboratory assays.

    Time frame: Baseline, 12 months, 24 months

  23. Exploratory: Change in Fibroblast Growth Factor 23 (FGF23) Levels

    Circulating FGF23 levels (pg/mL) will be measured using standard clinical laboratory assays.

    Time frame: Baseline, 12 months, 24 months

  24. Exploratory: Change in Wnt Inhibitory Factor-1 Levels

    Circulating Wnt Inhibitory Factor-1 (pg/dL) will be measured using standard clinical laboratory assays.

    Time frame: Baseline, 12 months, 24 months

  25. Exploratory: Change in Intact N-Terminal Propeptide of Type I Procollagen (P1NP) Levels

    Circulating P1NP levels (pg/mL) will be measured using standard clinical laboratory assays.

    Time frame: Baseline, 12 months, 24 months

  26. Exploratory: Change in Sclerostin Levels

    Circulating sclerostin levels (pg/mL) will be measured using standard clinical laboratory assays.

    Time frame: Baseline, 12 months, 24 months

  27. Exploratory: Change in Tartrate-Resistant Acid Phosphatase 5b (TRAP-5b) Levels

    Circulating TRAP-5b levels (U/L) will be measured using standard clinical laboratory assays.

    Time frame: Baseline, 12 months, 24 months

  28. Exploratory: Change in National Institutes of Health (NIH) Toolbox Fluid Cognition Composite Standard Score

    The NIH Toolbox Fluid Cognition Composite score assesses cognitive functions involved in processing and responding to new information, including attention, executive function, episodic memory, processing speed, and working memory. The age-adjusted Fluid Cognition Composite Standard Score is derived from participant performance on NIH Toolbox cognitive assessments and calculated according to NIH Toolbox scoring procedures. Scores are reported as standard scores without physical units, with a normative mean of 100 and standard deviation of 15. Scores of 70 or lower indicate significant impairment, scores around 85 are below average, scores around 100 are average, scores around 115 are above average, and scores around 130 are superior. Higher scores indicate better cognitive performance.

    Time frame: Baseline, 12 months, 24 months

  29. Exploratory: Change in Executive Function

    Executive function will be assessed using the NIH Toolbox Dimensional Change Card Sort Test. Change in the age-adjusted standard score will be derived from participant performance and calculated according to NIH Toolbox scoring procedures. Scores are reported as standard scores without physical units, with a normative mean of 100 and standard deviation of 15. Higher scores indicating better executive functioning.

    Time frame: Baseline, 12 months, 24 months

  30. Exploratory: Change in Attention/Inhibitory Control

    Attention and inhibitory control will be assessed using the NIH Toolbox Flanker Inhibitory Control Test. Change in the age-adjusted standard score will be derived from participant performance and calculated according to NIH Toolbox scoring procedures. Scores are reported as standard scores without physical units, with a normative mean of 100 and standard deviation of 15. Higher scores indicating better attention and inhibitory control.

    Time frame: Baseline, 12 months, 24 months

  31. Exploratory: Change in Processing Speed

    Processing speed will be assessed using the NIH Toolbox Pattern Comparison Processing Speed test. Change in the age-adjusted standard score will be derived from participant performance and calculated according to NIH Toolbox scoring procedures. Scores are reported as standard scores without physical units, with a normative mean of 100 and standard deviation of 15. Higher scores indicating better processing speed.

    Time frame: Baseline, 12 months, 24 months

  32. Exploratory: Change in Working Memory

    Working memory will be assessed using the NIH Toolbox List Sorting Working Memory Test. Change in the age-adjusted standard score will be derived from participant performance and calculated according to NIH Toolbox scoring procedures. Scores are reported as standard scores without physical units, with a normative mean of 100 and standard deviation of 15. Higher scores indicating better working memory.

    Time frame: Baseline, 12 months, 24 months

  33. Exploratory: Change in Episodic Memory

    Episodic memory will be assessed using the NIH Toolbox Picture Sequence Memory Test. Change in the age-adjusted standard score will be derived from participant performance and calculated according to NIH Toolbox scoring procedures. Scores are reported as standard scores without physical units, with a normative mean of 100 and standard deviation of 15. Higher scores indicating better episodic memory.

    Time frame: Baseline, 12 months, 24 months

  34. Exploratory: Change in Language/Vocabulary

    Language/Vocabulary will be assessed using the NIH Toolbox Picture Vocabulary Test and Oral Reading Recognition tests. Change in the age-adjusted standard score will be derived from participant performance and calculated according to NIH Toolbox scoring procedures. Scores are reported as standard scores without physical units, with a normative mean of 100 and standard deviation of 15. Higher scores indicating better language ability.

    Time frame: Baseline, 12 months, 24 months

  35. Exploratory: Change in Southwestern Assessment of Processing Speed (SWAPS) Score

    The SWAPS will be used to assess processing speed. Change in the normalized T-score will be derived from participant performance and calculated according to SWAPS scoring procedures. Scores are reported as T-scores without physical units, with a normative mean of 50 and standard deviation of 10. Higher scores indicate better processing speed performance.

    Time frame: Baseline, 12 months, 24 months

  36. Exploratory: Change in Texas Card Sorting Test (TCST) Score

    The TCST will be used to assess executive functioning, including cognitive flexibility and concept formation. Change in the normalized T-score will be derived from participant performance and calculated according to SWAPS scoring procedures. Scores are reported as T-scores without physical units, with a normative mean of 50 and standard deviation of 10. Higher scores indicate better executive functioning.

    Time frame: Baseline, 12 months, 24 months

  37. Exploratory: Change in Phosphorylated tau 217 (p-tau217) levels

    Circulating p-tau217 levels (pg/mL) will be measured using standard clinical laboratory assays.

    Time frame: Baseline, 12 months, 24 months

  38. Exploratory: Change in Amyloid-beta 42/40 ratio (Aβ42/40) Levels

    Circulating Aβ42 and Aβ40 levels (pg/mL) will be measured using standard clinical laboratory assays and the Aβ42/40 ratio calculated from these measurements and reported as a unitless ratio.

    Time frame: Baseline, 12 months, 24 months

  39. Exploratory: Change in Ankle-Brachial Index (ABI)

    ABI will be measured using semi-automated validated device (simpleABI-600CL). ABI values range from ≤0.90 (Peripheral artery disease), 0.91-0.99 (borderline), 1.00-1.40 (normal).ABI values \>1.40 indicate non-compressible arteries, suggestive of arterial stiffness or medial calcification. Both ABI values ≤0.90 and \>1.40 are associated with worse outcomes.

    Time frame: Baseline, 12 months, 24 months

  40. Exploratory: Change in Toe-Brachial Index (TBI)

    TBI will be measured using semi-automated validated device (simpleABI-600CL). TBI values range from ≥0.70 (normal), 0.64-0.69 (borderline), and \<0.40-0.50 (severe distal arterial disease/critical ischemia range). TBI values \<0.70 is a commonly used threshold suggestive of peripheral artery disease. Lower TBI values are associated with worse outcomes.

    Time frame: Baseline, 12 months, 24 months

  41. Exploratory: Change in Percentage of Participants with Ankle-Brachial Index (ABI) ≤0.9 or >1.4

    ABI will be measured using semi-automated validated device (simpleABI-600CL). The percentage (%) of participants with an ABI ≤0.9, indicative of peripheral arterial disease, or an ABI \>1.4, indicative of non-compressible arteries suggestive of arterial stiffness or medial calcification will be determined. Higher percentages indicate a greater proportion of participants with abnormal ABI findings.

    Time frame: Baseline, 12 months, 24 months

  42. Exploratory: Change in Urine Albumin-to-Creatine Ratio (uACR)

    Circulating urinary albumin and creatine levels (mg/dL) will be measured using standard clinical laboratory assays.

    Time frame: Baseline, 12 months, 24 months

  43. Exploratory: Change in Estimated Glomerular Filtration Rate (eGFR)

    eGFR values (mL/min/1.73m2) will be calculated using the NKF-ASN CKD-Epi refit formula.

    Time frame: Baseline, 12 months, 24 months

07

Study locations

1 site
08

References and documents

Publications

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  • Huang Z, Yaffe K, Li C, Xiao C, Pan Y, Sun X, Anderson AH, He J, Jaar BG, Han H, Kiryluk K, Rahman M, Rao P, Ricardo AC, Shah VO, Srivastava A, Taliercio JJ, Kurella Tamura M, Unruh ML, Weir MR, Lash JP, Bazzano LA, Chen J, Mills KT, Kelly TN; Chronic Renal Insufficiency Cohort (CRIC) Study Investigators. Chronic Kidney Disease Severity and Risk of Cognitive Impairment. JAMA Netw Open. 2026 Feb 2;9(2):e2559834. doi: 10.1001/jamanetworkopen.2025.59834. PubMed 41701494 ↗
  • Cunningham C, Hennessy E. Co-morbidity and systemic inflammation as drivers of cognitive decline: new experimental models adopting a broader paradigm in dementia research. Alzheimers Res Ther. 2015 Mar 24;7(1):33. doi: 10.1186/s13195-015-0117-2. eCollection 2015. PubMed 25802557 ↗
  • Ndumele CE, Neeland IJ, Tuttle KR, Chow SL, Mathew RO, Khan SS, Coresh J, Baker-Smith CM, Carnethon MR, Despres JP, Ho JE, Joseph JJ, Kernan WN, Khera A, Kosiborod MN, Lekavich CL, Lewis EF, Lo KB, Ozkan B, Palaniappan LP, Patel SS, Pencina MJ, Powell-Wiley TM, Sperling LS, Virani SS, Wright JT, Rajgopal Singh R, Elkind MSV, Rangaswami J; American Heart Association. A Synopsis of the Evidence for the Science and Clinical Management of Cardiovascular-Kidney-Metabolic (CKM) Syndrome: A Scientific Statement From the American Heart Association. Circulation. 2023 Nov 14;148(20):1636-1664. doi: 10.1161/CIR.0000000000001186. Epub 2023 Oct 9. PubMed 37807920 ↗
  • Budoff MJ, Bhandari M, Iskander B, Ghanem AK, Kinninger A, Stark J, Garikapati V, Chilukuri S, Hankil V, Krishnan S, Punnanithinont N, Ichikawa K, Kambalapalli S, Hamal S, Lakshmanan S. Effect of colchicine on progression of known coronary atherosclerosis in patients with stable coronary artery disease: EKSTROM randomized placebo controlled trial. Eur Heart J Cardiovasc Imaging. 2026 Mar 27;27(4):682-692. doi: 10.1093/ehjci/jeag028. PubMed 41670023 ↗
  • Nidorf SM, Fiolet ATL, Mosterd A, Eikelboom JW, Schut A, Opstal TSJ, The SHK, Xu XF, Ireland MA, Lenderink T, Latchem D, Hoogslag P, Jerzewski A, Nierop P, Whelan A, Hendriks R, Swart H, Schaap J, Kuijper AFM, van Hessen MWJ, Saklani P, Tan I, Thompson AG, Morton A, Judkins C, Bax WA, Dirksen M, Alings M, Hankey GJ, Budgeon CA, Tijssen JGP, Cornel JH, Thompson PL; LoDoCo2 Trial Investigators. Colchicine in Patients with Chronic Coronary Disease. N Engl J Med. 2020 Nov 5;383(19):1838-1847. doi: 10.1056/NEJMoa2021372. Epub 2020 Aug 31. PubMed 32865380 ↗
  • Absalon-Aguilar A, Rull-Gabayet M, Perez-Fragoso A, Mejia-Dominguez NR, Nunez-Alvarez C, Kershenobich-Stalnikowitz D, Sifuentes-Osornio J, Ponce-de-Leon A, Gonzalez-Lara F, Martin-Nares E, Montesinos-Ramirez S, Ramirez-Alemon M, Ramirez-Rangel P, Marquez MF, Plata-Corona JC, Juarez-Vega G, Gomez-Martin D, Torres-Ruiz J. Colchicine Is Safe Though Ineffective in the Treatment of Severe COVID-19: a Randomized Clinical Trial (COLCHIVID). J Gen Intern Med. 2022 Jan;37(1):4-14. doi: 10.1007/s11606-021-07203-8. Epub 2021 Nov 9. PubMed 34755269 ↗
  • Pan Y, Fan F, Jiang J, Zhang Y. Clinical outcomes of anti-inflammatory therapies inhibiting the NLRP3/IL-1beta/IL-6/CRP pathway in coronary artery disease patients: a systemic review and meta-analysis of 37,056 individuals from 32 randomized trials. Inflamm Res. 2025 Jun 30;74(1):99. doi: 10.1007/s00011-025-02058-9. PubMed 40583093 ↗
  • Yang S, Huang H, Jiang K, Peng Y, Liang Z, Gong X, Li L, Li Y, Zhang B, Chen Y, Yang X. Colchicine inhibits vascular calcification by suppressing inflammasome activation through the enhancement of the Sirt2-PP2Ac signaling pathway. J Biol Chem. 2025 Jul;301(7):110381. doi: 10.1016/j.jbc.2025.110381. Epub 2025 Jun 14. PubMed 40523615 ↗
  • Pan Z, Cheng J, Yang W, Chen L, Wang J. Effect of colchicine on inflammatory markers in patients with coronary artery disease: A meta-analysis of clinical trials. Eur J Pharmacol. 2022 Jul 15;927:175068. doi: 10.1016/j.ejphar.2022.175068. Epub 2022 May 27. PubMed 35644423 ↗
  • Kiraz S, Ertenli I, Arici M, Calguneri M, Haznedaroglu I, Celik I, Pay S, Kirazli S. Effects of colchicine on inflammatory cytokines and selectins in familial Mediterranean fever. Clin Exp Rheumatol. 1998 Nov-Dec;16(6):721-4. PubMed 9844766 ↗
  • Shi M, Zhang X, Li L, Wang Y, Zhao Q, Zhen Y, Huang Y, Liu C. Colchicine reduces inflammatory cytokines and improves symptoms in HFpEF: an observational pilot study. Front Med (Lausanne). 2026 Jan 16;12:1702293. doi: 10.3389/fmed.2025.1702293. eCollection 2025. PubMed 41625765 ↗
  • Astiawati T, Rohman MS, Wihastuti T, Sujuti H, Endharti A, Sargowo D, Oceandy D, Lestari B, Triastuti E, Nugraha RA. The Emerging Role of Colchicine to Inhibit NOD-like Receptor Family, Pyrin Domain Containing 3 Inflammasome and Interleukin-1beta Expression in In Vitro Models. Biomolecules. 2025 Mar 3;15(3):367. doi: 10.3390/biom15030367. PubMed 40149903 ↗
  • Liu Q, Yu L, Yin X, Ye J, Li S. Correlation Between Soluble Klotho and Vascular Calcification in Chronic Kidney Disease: A Meta-Analysis and Systematic Review. Front Physiol. 2021 Aug 13;12:711904. doi: 10.3389/fphys.2021.711904. eCollection 2021. PubMed 34483963 ↗
  • Ayu NP, Kandarini Y, Widiana R, Mahadita GW. Fetuin-A as a risk factor for arteriovenous fistula failure in chronic kidney disease patients with hemodialysis through vascular calcification mechanism: Systematic review and meta-analysis. J Vasc Access. 2026 Jul;27(4):1450-1462. doi: 10.1177/11297298251407274. Epub 2026 Jan 16. PubMed 41542792 ↗
  • Henaut L, Massy ZA. New insights into the key role of interleukin 6 in vascular calcification of chronic kidney disease. Nephrol Dial Transplant. 2018 Apr 1;33(4):543-548. doi: 10.1093/ndt/gfx379. No abstract available. PubMed 29420799 ↗
  • Pang Q, Wang P, Pan Y, Dong X, Zhou T, Song X, Zhang A. Irisin protects against vascular calcification by activating autophagy and inhibiting NLRP3-mediated vascular smooth muscle cell pyroptosis in chronic kidney disease. Cell Death Dis. 2022 Mar 30;13(3):283. doi: 10.1038/s41419-022-04735-7. PubMed 35354793 ↗
  • Bundy JD, Chen J, Yang W, Budoff M, Go AS, Grunwald JE, Kallem RR, Post WS, Reilly MP, Ricardo AC, Rosas SE, Zhang X, He J; CRIC Study Investigators. Risk factors for progression of coronary artery calcification in patients with chronic kidney disease: The CRIC study. Atherosclerosis. 2018 Apr;271:53-60. doi: 10.1016/j.atherosclerosis.2018.02.009. Epub 2018 Feb 10. PubMed 29459266 ↗
  • Cummings SR, San Martin J, McClung MR, Siris ES, Eastell R, Reid IR, Delmas P, Zoog HB, Austin M, Wang A, Kutilek S, Adami S, Zanchetta J, Libanati C, Siddhanti S, Christiansen C; FREEDOM Trial. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med. 2009 Aug 20;361(8):756-65. doi: 10.1056/NEJMoa0809493. Epub 2009 Aug 11. PubMed 19671655 ↗
  • Nitta K, Akiba T, Suzuki K, Uchida K, Watanabe R, Majima K, Aoki T, Nihei H. Effects of cyclic intermittent etidronate therapy on coronary artery calcification in patients receiving long-term hemodialysis. Am J Kidney Dis. 2004 Oct;44(4):680-8. PubMed 15384019 ↗
  • Neven EG, De Broe ME, D'Haese PC. Prevention of vascular calcification with bisphosphonates without affecting bone mineralization: a new challenge? Kidney Int. 2009 Mar;75(6):580-2. doi: 10.1038/ki.2008.663. PubMed 19247382 ↗
  • Price PA, Faus SA, Williamson MK. Bisphosphonates alendronate and ibandronate inhibit artery calcification at doses comparable to those that inhibit bone resorption. Arterioscler Thromb Vasc Biol. 2001 May;21(5):817-24. doi: 10.1161/01.atv.21.5.817. PubMed 11348880 ↗
  • Imanishi Y, Furukubo T, Shoji S. Clinical approaches to osteoporosis in patients with chronic kidney disease: A comprehensive review. Endocr J. 2025 Aug 1;72(8):847-862. doi: 10.1507/endocrj.EJ24-0271. Epub 2025 Apr 23. PubMed 40268403 ↗
  • Xu B, Ma R, Wu Y, Liu C, Song X. Immune mechanisms in chronic kidney disease-mineral and bone disorder: current insights and therapeutic implications. Front Med (Lausanne). 2025 Oct 9;12:1678640. doi: 10.3389/fmed.2025.1678640. eCollection 2025. PubMed 41140655 ↗
  • Zhao Y, Li H, Guo Y. Interleukin family in vascular calcification: molecular mechanisms and therapeutic perspectives. Front Cardiovasc Med. 2025 Sep 1;12:1619018. doi: 10.3389/fcvm.2025.1619018. eCollection 2025. PubMed 40959491 ↗
  • Mazzaferro S, De Martini N, Rotondi S, Tartaglione L, Urena-Torres P, Bover J, Pasquali M; ERA-EDTA Working Group on CKD-MBD. Bone, inflammation and chronic kidney disease. Clin Chim Acta. 2020 Jul;506:236-240. doi: 10.1016/j.cca.2020.03.040. Epub 2020 Apr 8. PubMed 32275989 ↗
  • Mazzaferro S, Bagordo D, De Martini N, Pasquali M, Rotondi S, Tartaglione L, Stenvinkel P; ERA-EDTA CKD-MBD working group. Inflammation, Oxidative Stress, and Bone in Chronic Kidney Disease in the Osteoimmunology Era. Calcif Tissue Int. 2021 Apr;108(4):452-460. doi: 10.1007/s00223-020-00794-0. Epub 2021 Jan 2. PubMed 33388898 ↗
  • Gupta J, Mitra N, Kanetsky PA, Devaney J, Wing MR, Reilly M, Shah VO, Balakrishnan VS, Guzman NJ, Girndt M, Periera BG, Feldman HI, Kusek JW, Joffe MM, Raj DS; CRIC Study Investigators. Association between albuminuria, kidney function, and inflammatory biomarker profile in CKD in CRIC. Clin J Am Soc Nephrol. 2012 Dec;7(12):1938-46. doi: 10.2215/CJN.03500412. Epub 2012 Sep 27. PubMed 23024164 ↗
  • Amdur RL, Feldman HI, Gupta J, Yang W, Kanetsky P, Shlipak M, Rahman M, Lash JP, Townsend RR, Ojo A, Roy-Chaudhury A, Go AS, Joffe M, He J, Balakrishnan VS, Kimmel PL, Kusek JW, Raj DS; CRIC Study Investigators. Inflammation and Progression of CKD: The CRIC Study. Clin J Am Soc Nephrol. 2016 Sep 7;11(9):1546-1556. doi: 10.2215/CJN.13121215. Epub 2016 Jun 23. PubMed 27340285 ↗
  • Lee BT, Ahmed FA, Hamm LL, Teran FJ, Chen CS, Liu Y, Shah K, Rifai N, Batuman V, Simon EE, He J, Chen J. Association of C-reactive protein, tumor necrosis factor-alpha, and interleukin-6 with chronic kidney disease. BMC Nephrol. 2015 May 30;16:77. doi: 10.1186/s12882-015-0068-7. PubMed 26025192 ↗
  • Vilaca T, Salam S, Schini M, Harnan S, Sutton A, Poku E, Allen IE, Cummings SR, Eastell R. Risks of Hip and Nonvertebral Fractures in Patients With CKD G3a-G5D: A Systematic Review and Meta-analysis. Am J Kidney Dis. 2020 Oct;76(4):521-532. doi: 10.1053/j.ajkd.2020.02.450. Epub 2020 Jul 9. PubMed 32654892 ↗
  • She C, Liu H. Construction and validation of a predictive model for the risk of osteoporosis in patients with chronic kidney disease based on NHANES data. PLoS One. 2025 Feb 6;20(2):e0316494. doi: 10.1371/journal.pone.0316494. eCollection 2025. PubMed 39913394 ↗
  • Kestenbaum B, Sampson JN, Rudser KD, Patterson DJ, Seliger SL, Young B, Sherrard DJ, Andress DL. Serum phosphate levels and mortality risk among people with chronic kidney disease. J Am Soc Nephrol. 2005 Feb;16(2):520-8. doi: 10.1681/ASN.2004070602. Epub 2004 Dec 22. PubMed 15615819 ↗
  • Magagnoli L, Cozzolino M, Caskey FJ, Evans M, Torino C, Porto G, Szymczak M, Krajewska M, Drechsler C, Stenvinkel P, Pippias M, Dekker FW, de Rooij ENM, Wanner C, Chesnaye NC, Jager KJ; EQUAL study investigators. Association between CKD-MBD and mortality in older patients with advanced CKD-results from the EQUAL study. Nephrol Dial Transplant. 2023 Oct 31;38(11):2562-2575. doi: 10.1093/ndt/gfad100. PubMed 37230954 ↗
  • Geng S, Kuang Z, Peissig PL, Page D, Maursetter L, Hansen KE. Parathyroid hormone independently predicts fracture, vascular events, and death in patients with stage 3 and 4 chronic kidney disease. Osteoporos Int. 2019 Oct;30(10):2019-2025. doi: 10.1007/s00198-019-05033-3. Epub 2019 May 31. PubMed 31190122 ↗
  • Isakova T, Xie H, Yang W, Xie D, Anderson AH, Scialla J, Wahl P, Gutierrez OM, Steigerwalt S, He J, Schwartz S, Lo J, Ojo A, Sondheimer J, Hsu CY, Lash J, Leonard M, Kusek JW, Feldman HI, Wolf M; Chronic Renal Insufficiency Cohort (CRIC) Study Group. Fibroblast growth factor 23 and risks of mortality and end-stage renal disease in patients with chronic kidney disease. JAMA. 2011 Jun 15;305(23):2432-9. doi: 10.1001/jama.2011.826. PubMed 21673295 ↗
  • Isakova T, Cai X, Lee J, Xie D, Wang X, Mehta R, Allen NB, Scialla JJ, Pencina MJ, Anderson AH, Talierco J, Chen J, Fischer MJ, Steigerwalt SP, Leonard MB, Hsu CY, de Boer IH, Kusek JW, Feldman HI, Wolf M; Chronic Renal Insufficiency Cohort (CRIC) Study Investigators. Longitudinal FGF23 Trajectories and Mortality in Patients with CKD. J Am Soc Nephrol. 2018 Feb;29(2):579-590. doi: 10.1681/ASN.2017070772. Epub 2017 Nov 22. PubMed 29167351 ↗
  • Wang XR, Zhang JJ, Xu XX, Wu YG. Prevalence of coronary artery calcification and its association with mortality, cardiovascular events in patients with chronic kidney disease: a systematic review and meta-analysis. Ren Fail. 2019 Nov;41(1):244-256. doi: 10.1080/0886022X.2019.1595646. PubMed 31014155 ↗
  • Yamada S, Nakano T. Role of Chronic Kidney Disease (CKD)-Mineral and Bone Disorder (MBD) in the Pathogenesis of Cardiovascular Disease in CKD. J Atheroscler Thromb. 2023 Aug 1;30(8):835-850. doi: 10.5551/jat.RV22006. Epub 2023 May 30. PubMed 37258233 ↗
  • Tian L, Jaeger BC, Scialla JJ, Budoff MJ, Mehta RC, Jaar BG, Saab G, Dobre MA, Reilly MP, Rader DJ, Townsend RR, Lash JP, Greenland P, Isakova T, Bundy JD; CRIC Study Investigators. Progression of Coronary Artery Calcification and Risk of Clinical Events in CKD: The Chronic Renal Insufficiency Cohort Study. Am J Kidney Dis. 2025 Jan;85(1):67-77.e1. doi: 10.1053/j.ajkd.2024.06.018. Epub 2024 Aug 16. PubMed 39154888 ↗
  • Chen J, Budoff MJ, Reilly MP, Yang W, Rosas SE, Rahman M, Zhang X, Roy JA, Lustigova E, Nessel L, Ford V, Raj D, Porter AC, Soliman EZ, Wright JT Jr, Wolf M, He J; CRIC Investigators. Coronary Artery Calcification and Risk of Cardiovascular Disease and Death Among Patients With Chronic Kidney Disease. JAMA Cardiol. 2017 Jun 1;2(6):635-643. doi: 10.1001/jamacardio.2017.0363. PubMed 28329057 ↗

Individual participant data

Plan to share: Yes — IRB approval is required before sharing IPD.

Supporting information: Study protocol, Statistical analysis plan

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Start is estimated for Oct 2026; primary completion for May 2029, 30 months later.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 4, 2026: start Jul 2026 → Oct 2026, primary completion Dec 2027 → May 2029 and completion Dec 2027 → May 2029.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jun 11, 2026
First posted
Jun 17, 2026
StartEst.
Oct 30, 2026was Jul 2026
Primary completionEst.
May 1, 2029was Dec 2027
CompletionEst.
May 1, 2029was Dec 2027
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Jul 1, 2026→Oct 30, 2026
Nov 4, 2026
Primary completion
Dec 1, 2027→May 1, 2029
Nov 4, 2026
Study completion
Dec 31, 2027→May 1, 2029
Nov 4, 2026
Eligibility
Minimum age 18 Years→30 Years; 3 inclusion criteria edited, 2 removed; 4 exclusion criteria edited, 6 added, 2 removed
What changed in the criteria
Inclusion criteria
  • EditedMen and women aged 1830-<70 years of all race/ethnicity groups
  • EditedChronic kidney disease (CKD) stage 3 (estimated glomerular filtration rate (eGFR) >30 to 59<60 ml/min/1.73m2) or eGFR ≥60 and Urine albumin-to-creatinine ratio (uACR) ≥ 30 mg/g
  • RemovedUrine albumin-to-creatinine ratio (uACR) ≥ 200 mg/g
  • EditedCardiac artery calcification (CAC) Agatston score ≥30100-1000
  • RemovedHypertension, diabetes, dyslipidemia, or established atherosclerotic cardiovascular disease (ASCVD) (coronary artery disease (CAD), ischemic stroke, and peripheral artery disease), defined by self-report, ICD-10 codes, or the use of medications for these conditions.
Exclusion criteria
  • AddedEstablished peripheral arterial disease (PAD) defined by self-report or ICD-10 codes
  • AddedCongestive heart failure classified as New York Heart Association (NYHA) Functional class III or IV
  • AddedUncontrolled atrial fibrillation with resting heart rate > 100 beats/min
  • AddedDementia defined by self-report or ICD-10 codes (F01-F03)
  • AddedAlzheimer's disease defined by self-report or ICD-10 codes (G30)
  • RemovedImmunosuppression
  • AddedImmunosuppression, including the use of immunosuppressive medications
  • RemoveduACR <200 mg/g
  • EditedWhite blood cell count (WBC) <3.0 x109x10\^9/L
  • EditedUses nicotine products or other recreational drugs
  • EditedUnable to undergo to computed tomography (CT) or dual-energy X-ray absorptiometry (DXA) scans
  • EditedUnable to read orand speak English or Spanish
Nov 4, 2026
Primary outcomes
1 time frame changed, 1 added, 1 description edited
What changed in the outcomes
  • AddedChange in Coronary Artery Calcification Volume ScoresTime frame: Baseline, 12 months, 24 months
  • Time frameChange in Coronary Artery Calcification Agatston ScoresBaseline, 12 months → Baseline, 12 months, 24 months
  • DescriptionChange in Coronary Artery Calcification Agatston Scores: how it is measured was reworded
Nov 4, 2026
Secondary outcomes
10 added, 20 removed, 34 more
What changed in the outcomes
  • RemovedChange in Coronary Artery Calcification Volume ScoresTime frame: Baseline, 12 months
  • RemovedChange in Cardiac Artery Calcification Mass ScoresTime frame: Baseline, 12 months
  • RemovedChange in Serum Klotho LevelsTime frame: Baseline, 6 months, 12 months
  • RemovedChange in Fetuin A LevelsTime frame: Baseline, 6 months, 12 months
  • RemovedChange in Serum Phosphate levelsTime frame: Baseline, 6 months, 12 months
  • RemovedChange in Serum Calcium LevelsTime frame: Baseline, 6 months, 12 months
  • RemovedChange in Parathyroid Hormone (PTH) levelsTime frame: Baseline, 6 months, 12 months
  • RemovedChange in C-terminal Fibroblast Growth Factor 23 (FGF23) LevelsTime frame: Baseline, 6 months, 12 months
  • RemovedChange in Fibroblast Growth Factor 23 (FGF23) LevelsTime frame: Baseline, 6 months, 12 months
  • RemovedChange in Bone-Specific Alkaline Phosphatase (BSAP) LevelsTime frame: Baseline, 6 months, 12 months
  • RemovedChange in C-terminal Telopeptide of Type I Collagen (CTX)Time frame: Baseline, 6 months, 12 months
  • RemovedChange in Tartrate-Resistant Acid Phosphatase 5b (TRAP-5b) LevelsTime frame: Baseline, 6 months, 12 months
  • RemovedChange in Sclerostin LevelsTime frame: Baseline, 6 months, 12 months
  • RemovedChange in Lumbar Spine Bone Mineral Density (BMD)Time frame: Baseline, 12 months
  • RemovedChange in Hip Bone Mineral Density (BMD)Time frame: Baseline, 12 months
  • RemovedChange in Radius Bone Mineral Density (BMD)Time frame: Baseline, 12 months
  • RemovedChange in Interleukin-6 (IL-6) LevelsTime frame: Baseline, 6 months, 12 months
  • RemovedChange in Soluble Tumor Necrosis Factor Receptor 1 (sTNFR1) LevelsTime frame: Baseline, 6 months, 12 months
  • RemovedChange in Interleukin-17 (IL-17) LevelsTime frame: Baseline, 6 months, 12 months
  • RemovedChange in Intact N-Terminal Propeptide of Type I Procollagen (P1NP) LevelsTime frame: Baseline, 6 months, 12 months
  • Addedother outcomeExploratory: Change in Aortic Valve Calcification Agatston ScoresTime frame: Baseline, 12 months, 24 months
  • Addedother outcomeExploratory: Change in Aortic Valve Calcification Volume ScoresTime frame: Baseline, 12 months, 24 months
  • Addedother outcomeExploratory: Change in Mitral Annular Calcification Agatston ScoresTime frame: Baseline, 12 months, 24 months
  • Addedother outcomeExploratory: Change in Mitral Annular Calcification Volume ScoresTime frame: Baseline, 12 months, 24 months
  • Addedother outcomeExploratory: Change in Vertebral Bone Mineral Density (BMD)Time frame: Baseline, 12 months, 24 months
  • Addedother outcomeExploratory: Change in C-Reactive Protein (CRP) LevelsTime frame: Baseline, 12 months, 24 months
  • Addedother outcomeExploratory: Change in Interleukin-1 beta (IL-1β) LevelsTime frame: Baseline, 12 months, 24 months
  • Addedother outcomeExploratory: Change in Interleukin-6 (IL-6) LevelsTime frame: Baseline, 12 months, 18 months
  • Addedother outcomeExploratory: Change in Interleukin-18 (IL-18) LevelsTime frame: Baseline, 12 months, 24 months
  • Addedother outcomeExploratory: Change in Tumor Necrosis Factor alphaTime frame: Baseline, 12 months, 24 months
  • …and 34 more, on the record history on ClinicalTrials.gov ↗
Nov 4, 2026
Title
Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD→REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    Start date Jul 1, 2026→Oct 30, 2026
    Primary completion Dec 1, 2027→May 1, 2029
    Study completion Dec 31, 2027→May 1, 2029
    Eligibility Minimum age 18 Years→30 Years; 3 inclusion criteria edited, 2 removed; 4 exclusion criteria edited, 6 added, 2 removed
    What changed in the criteria
    Inclusion criteria
    • EditedMen and women aged 1830-<70 years of all race/ethnicity groups
    • EditedChronic kidney disease (CKD) stage 3 (estimated glomerular filtration rate (eGFR) >30 to 59<60 ml/min/1.73m2) or eGFR ≥60 and Urine albumin-to-creatinine ratio (uACR) ≥ 30 mg/g
    • RemovedUrine albumin-to-creatinine ratio (uACR) ≥ 200 mg/g
    • EditedCardiac artery calcification (CAC) Agatston score ≥30100-1000
    • RemovedHypertension, diabetes, dyslipidemia, or established atherosclerotic cardiovascular disease (ASCVD) (coronary artery disease (CAD), ischemic stroke, and peripheral artery disease), defined by self-report, ICD-10 codes, or the use of medications for these conditions.
    Exclusion criteria
    • AddedEstablished peripheral arterial disease (PAD) defined by self-report or ICD-10 codes
    • AddedCongestive heart failure classified as New York Heart Association (NYHA) Functional class III or IV
    • AddedUncontrolled atrial fibrillation with resting heart rate > 100 beats/min
    • AddedDementia defined by self-report or ICD-10 codes (F01-F03)
    • AddedAlzheimer's disease defined by self-report or ICD-10 codes (G30)
    • RemovedImmunosuppression
    • AddedImmunosuppression, including the use of immunosuppressive medications
    • RemoveduACR <200 mg/g
    • EditedWhite blood cell count (WBC) <3.0 x109x10\^9/L
    • EditedUses nicotine products or other recreational drugs
    • EditedUnable to undergo to computed tomography (CT) or dual-energy X-ray absorptiometry (DXA) scans
    • EditedUnable to read orand speak English or Spanish
    Primary outcomes 1 time frame changed, 1 added, 1 description edited
    What changed in the outcomes
    • AddedChange in Coronary Artery Calcification Volume ScoresTime frame: Baseline, 12 months, 24 months
    • Time frameChange in Coronary Artery Calcification Agatston ScoresBaseline, 12 months → Baseline, 12 months, 24 months
    • DescriptionChange in Coronary Artery Calcification Agatston Scores: how it is measured was reworded
    Secondary outcomes 10 added, 20 removed, 34 more
    What changed in the outcomes
    • RemovedChange in Coronary Artery Calcification Volume ScoresTime frame: Baseline, 12 months
    • RemovedChange in Cardiac Artery Calcification Mass ScoresTime frame: Baseline, 12 months
    • RemovedChange in Serum Klotho LevelsTime frame: Baseline, 6 months, 12 months
    • RemovedChange in Fetuin A LevelsTime frame: Baseline, 6 months, 12 months
    • RemovedChange in Serum Phosphate levelsTime frame: Baseline, 6 months, 12 months
    • RemovedChange in Serum Calcium LevelsTime frame: Baseline, 6 months, 12 months
    • RemovedChange in Parathyroid Hormone (PTH) levelsTime frame: Baseline, 6 months, 12 months
    • RemovedChange in C-terminal Fibroblast Growth Factor 23 (FGF23) LevelsTime frame: Baseline, 6 months, 12 months
    • RemovedChange in Fibroblast Growth Factor 23 (FGF23) LevelsTime frame: Baseline, 6 months, 12 months
    • RemovedChange in Bone-Specific Alkaline Phosphatase (BSAP) LevelsTime frame: Baseline, 6 months, 12 months
    • RemovedChange in C-terminal Telopeptide of Type I Collagen (CTX)Time frame: Baseline, 6 months, 12 months
    • RemovedChange in Tartrate-Resistant Acid Phosphatase 5b (TRAP-5b) LevelsTime frame: Baseline, 6 months, 12 months
    • RemovedChange in Sclerostin LevelsTime frame: Baseline, 6 months, 12 months
    • RemovedChange in Lumbar Spine Bone Mineral Density (BMD)Time frame: Baseline, 12 months
    • RemovedChange in Hip Bone Mineral Density (BMD)Time frame: Baseline, 12 months
    • RemovedChange in Radius Bone Mineral Density (BMD)Time frame: Baseline, 12 months
    • RemovedChange in Interleukin-6 (IL-6) LevelsTime frame: Baseline, 6 months, 12 months
    • RemovedChange in Soluble Tumor Necrosis Factor Receptor 1 (sTNFR1) LevelsTime frame: Baseline, 6 months, 12 months
    • RemovedChange in Interleukin-17 (IL-17) LevelsTime frame: Baseline, 6 months, 12 months
    • RemovedChange in Intact N-Terminal Propeptide of Type I Procollagen (P1NP) LevelsTime frame: Baseline, 6 months, 12 months
    • Addedother outcomeExploratory: Change in Aortic Valve Calcification Agatston ScoresTime frame: Baseline, 12 months, 24 months
    • Addedother outcomeExploratory: Change in Aortic Valve Calcification Volume ScoresTime frame: Baseline, 12 months, 24 months
    • Addedother outcomeExploratory: Change in Mitral Annular Calcification Agatston ScoresTime frame: Baseline, 12 months, 24 months
    • Addedother outcomeExploratory: Change in Mitral Annular Calcification Volume ScoresTime frame: Baseline, 12 months, 24 months
    • Addedother outcomeExploratory: Change in Vertebral Bone Mineral Density (BMD)Time frame: Baseline, 12 months, 24 months
    • Addedother outcomeExploratory: Change in C-Reactive Protein (CRP) LevelsTime frame: Baseline, 12 months, 24 months
    • Addedother outcomeExploratory: Change in Interleukin-1 beta (IL-1β) LevelsTime frame: Baseline, 12 months, 24 months
    • Addedother outcomeExploratory: Change in Interleukin-6 (IL-6) LevelsTime frame: Baseline, 12 months, 18 months
    • Addedother outcomeExploratory: Change in Interleukin-18 (IL-18) LevelsTime frame: Baseline, 12 months, 24 months
    • Addedother outcomeExploratory: Change in Tumor Necrosis Factor alphaTime frame: Baseline, 12 months, 24 months
    • …and 34 more, on the record history on ClinicalTrials.gov ↗
    Title Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD→REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
    + 6 other changes: index terms, verification date, description, conditions, design details and references

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07654231
Responsible party
Jing Chen (Professor, University of Texas Southwestern Medical Center) — Principal investigator
First posted
Jun 17, 2026
Start date
Oct 30, 2026 (estimated)
Primary completion
May 1, 2029 (estimated)
Completion
May 1, 2029 (estimated)
Last update
Nov 4, 2026

Study contacts

Alexandra R Hartman
Contact
RESOLVE-CKD@UTSouthwestern.edu
614-420-1186
Paola Lanza, MD
Contact
paola.lanza@UTSouthwestern.edu
469-852-9550
Jing Chen, MD
principal investigator · University of Texas

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Colchicine

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