An observational study in Chronic Kidney Disease stage3, Chronic Kidney Disease stage4 and Chronic Kidney Disease Stage 1, sponsored by Cardenal Herrera University. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-12-30.
Sponsored by Cardenal Herrera University · Observational
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Among 187 studies in Renal Insufficiency, Chronic with a site in Spain — 37 open to participants now, 54 under way, 23 of them phase 3. Renal Insufficiency, Chronic · Spain.
Among the 187 studies in Renal Insufficiency, Chronic with a site in Spain, this one is the 22nd largest by planned enrollment of the 34 observational ones that give a count, is one of 7 that started in 2023, is one of 34 observational ones, reaches primary completion later than 25 of the 53 other live ones, and was the 171st registered.
3,095 studies on the registry are indexed under Renal Insufficiency, Chronic; 701 are open to participants now.
Browse Renal Insufficiency, Chronic studies →37 of the 187 studies in Renal Insufficiency, Chronic with a site in Spain are open now. Recruiting first, the newest first:
Cardenal Herrera University · Sites in Spain
Ages 18–85
AstraZeneca · Sites in Spain, United States, Argentina and 24 more countries
Ages 18–99
AstraZeneca · Sites in Spain, United States, Argentina and 34 more countries
Ages 18+
Novartis Pharmaceuticals · Sites in Spain, United States, China and 5 more countries
Ages 2–18
Vifor Fresenius Medical Care Renal Pharma · Sites in Spain, China, Greece and 4 more countries
Ages 12–18
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 435 Renal Insufficiency, Chronic studies recruiting now, 244 (56%) set no upper age limit and 111 (26%) stop at 75 or younger; 45 take children under 18; 80 take healthy volunteers.
This study: 18 Years to 90 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
187 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 34 · Phase 3 80 · Phase 4 14
First in 1998; this study’s year is marked. 7 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 250 is above the median of 213 across 834 observational studies indexed under Renal Insufficiency, Chronic.
Median enrollment 252 across the 153 interventional studies, 397 across the 34 observational. Of the 122 that completed or were terminated, 68 (56%) have results posted.
This tab as a report to print or save as PDF → With an account.
124 of 187 have an industry lead sponsor. The 10 most frequent:
Cardenal Herrera University is the lead sponsor of 108 studies on the registry; 22 are open to participants now.
Cardenal Herrera University has 6 studies filed under Renal Insufficiency, Chronic — fewer than ten, so there is no comparison to draw.
13 of the studies in Renal Insufficiency, Chronic with a site in Spain that are under way reach primary completion within a year, 8 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06578078Phase 3Fundación para la Investigación del Hospital Clínico de ValenciaA Clinical Trial to Define the Best Strategy for the Management of Heart Failure in Elderly Patients | 2026-12-30 |
| NCT05196035Phase 3BayerA Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria | 2027-04-10 |
| NCT07107945Phase 3Boehringer IngelheimA Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids) | 2027-04-16 |
| NCT03969329Phase 3AmgenA Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis | 2027-06-30 |
| NCT05374291Phase 3University Medical Center GroningenThe RENAL LIFECYCLE Trial: A RCT to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Severe CKD | 2027-07 |
Add all 13 to your calendar (.ics) → With an account.
Among the 187 studies in Renal Insufficiency, Chronic with a site in Spain, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Chronic kidney disease (CKD) is the progressive damage to kidney function, associated with an increased risk of cardiovascular diseases, such as stroke or myocardial infarct, particularly in the most severe stages of CKD, in which the patient requires dialysis. Several risk factors are reported for CKD, such as diabetes mellitus, obesity and hypertension. One of the most increasingly recognized risk factors is the fat tissue malfunction, known as adiposopathy. The accumulation of fat tissue around the organs in conditions of obesity or diabetes accelerates the production of pro-inflammatory factors that may worsen the kidney and heart damage. New antidiabetic medications, such as glucagon-like peptide-1 receptor agonists (GLP-1RA), have proven beneficial effects on the kidney and heart due to several mechanisms, including anti-inflammatory actions and a potential action on the fat tissue.
The aim of this study is to assess the link between adiposopathy and CKD, by investigating the changes in adiposopathy measures throughout treatment with GLP-1RA to a sample of patients with CKD.
Chronic kidney disease (CKD) is defined as an irreversible abnormality of kidney structure and/or function lasting for more than three months. CKD is a major global health burden, affecting over 10% of the worldwide population and representing a leading cause of morbidity and mortality. Its progression to end-stage kidney disease (ESKD) drastically increases cardiovascular risk and is associated with a five-year survival rate of only approximately 50%. The principal risk factors for CKD-hypertension, obesity and type 2 diabetes (T2DM) in particular-are intrinsically linked through the dysfunction of fat/adipose tissue (AT), also known as adiposopathy.
Adiposopathy is a key driver of cardiorenal risk in CKD. Evidence from bioimpedance, imaging techniques (CT, MRI), and molecular biology studies confirm that alterations in adipose tissue-including its quantity, distribution (e.g., perirenal, epicardial), radiodensity, and the secretion of pro-inflammatory adipokines-are powerful triggers of cardiorenal damage and mortality in these patients. This understanding frames obesity, T2DM, cardiovascular diseases (CVDs), and CKD as different manifestations of a shared spectrum, now termed adiposity-based chronic disease (ABCD), necessitating an "adipocentric" therapeutic approach.
One hallmark feature of adiposopathy is the reprogramming and increase in size of certain region-specific adipose tissue. Perivisceral adipose tissue plays a pivotal role in adiposity-based chronic diseases as it releases adipokines and cytokines that not only contribute to the systemic pro-inflammatory and oxidative stress processes but may also influence the function of the organs surrounded by this tissue.
GLP-1RA stimulates the receptor for glucagon-like peptide-1 (GLP-1), an incretin-like hormone released in the large intestine that reduces serum glucose concentrations by stimulating the glucose-dependent release of insulin, inhibiting the hypersecretion of glucagon (except in hypoglycemia periods) and promoting satiety. GLP-1RA reduced the incidence of cardiovascular death in patients with T2DM compared with placebo and decreased the incidence of major kidney events, also reducing the progression of kidney dysfunction and the risk of death. In animals, the observed morphological changes generated by GLP-1RA could be underlined by potential actions on adipose tissue remodeling, as these drugs upregulated the expression of AT-browning related genes in perivisceral white adipose tissue from murine models, although the transcriptomic effects from GLP-1RA on the adiposopathy process are still unknown.
Patients will be assigned to the different groups according to current treatment criteria:
SGLT2i: patients with CKD and T2DM with an eGFR ≥20ml/min/1.73m2; patients with CKD and eGFR ≥20ml/min/1.73m2, accompanied by an urinary albumin-to-creatinine ratio (ACR) ≥200mg/g; patients with CKD and heart failure, irrespective of level of albuminuria; or subjects with CKD and eGFR 20-45ml/min/1.73m2, with ACR \<200mg/g.
GLP-1RA/tirzepatide: In patients with T2D and CKD who have not achieved individualized glycemic targets despite use of metformin and SGLT2i treatment, or who are unable to use those medications.
Other treatments: patients not meeting the criteria to be treated with SGLT2i or GLP-1RA/tirzepatide
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.
Exclusion Criteria:
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receiving GLP-1RA, mainly semaglutide: weekly administration, subcutaneous form, from 0.25mg (starting dose) to 1mg (maintenance dose) with monthly increase (0.25-0.5-1mg)
Drug: GLP-1 receptor agonist · Drug: SGLT2 inhibitor
There will also be another comparative group of patients under SGLT2i
Drug: GLP-1 receptor agonist · Drug: SGLT2 inhibitor
Patients not under SGLT2i or GLP-1RA/Tirzepatide influence, but receiving other treatments that are part of CKD and diabetes standard care
Patients receiving tirzepatide: weekly administration, subcutaneous form, starting dose 2.5mg, maintenance 5mg
Drug: Tirzepatide · Drug: Other drugs
Semaglutide: weekly subcutaneous administration, starting dose 0.25mg, maintenance dose 1mg
Also known as: semaglutide, liraglutide, dulaglutide, exenatide
dapagliflozin: oral administration from 5 to 10mg/day
Also known as: dapagliflozin, empagliflozin, canagliflozin
subcutaneous injection: starting dose 2.5 mg, maintenance 5mg (weekly administration)
Patients not under SGLT2i or GLP-1RA influence, but receiving other treatments which are part of CKD standard care: mineralocorticoid receptor agonists, metformin, ACE inhibitors, ARBs...
Also known as: ARBs, ACE inhibitors, Metformin, DPP4i, non steroidal mineralocorticoid receptor agonists
This study also gives Semaglutide. No intervention listed here names it: that was found by reading the record.
Ultrasonography change in perirenal adipose tissue thickness
Change in perirenal adipose tissue thickness as measured with ultrasonography
Time frame: 16 months
Change in estimated glomerular filtration rate
Change in eGFR as per the CKD-EPI formula
Time frame: 16 months
Ultrasonographic Change in epicardial adipose tissue thickness
Change in epicardial adipose tissue thickness as measured with ultrasonography
Time frame: 16 months
Change in serum leptin levels
Serum leptin levels measured with proteomic analysis
Time frame: 16 months
Change in visceral fat area
Changes in visceral fat area (cm2) as measured with body composition measures (bioimpedance)
Time frame: 16 months
Ultrasonographic Change in subcutaneous adipose tissue
Change in subcutaneous adipose tissue thickness as measured with ultrasonography
Time frame: 16 months
Ultrasonographic Change in preperitoneal adipose tissue thickness
Change in preperitoneal adipose tissue thickness as measured with ultrasonography
Time frame: 16 months
Ultrasonographic Change in intrahepatic adipose tissue
Change in intrahepatic adipose tissue echogenicity
Time frame: 16 months
Change in subcutaneous fat area
Change in subcutaneous fat area (cm2) as measured with bioimpedance
Time frame: 16 months
Changes in muscle mass (kg)
Changes in muscle mass as measured with bioimpedance
Time frame: 16 months
Change in serum adiponectin levels
Serum adiponectin levels measured with proteomic analysis
Time frame: 16 months
Change in urinary levels of Kidney Injury Molecule-1
Change in urinary levels of KIM-1 measured with ELISA, as an early marker of kidney damage
Time frame: 16 months
Change in systemic inflammation markers
Change in serum C-reactive protein levels
Time frame: 16 months
Change in systemic inflammation markers
Change in serum interleukin-6 levels
Time frame: 16 months
Change in systemic inflammation markers
Change in serum tumor necrosis factor-alpha levels
Time frame: 16 months
Plan to share: No — Due to ethical restrictions and in accordance with General Protection Data Regulation, no identifiable patient information will be shared.
Started Sep 2023 (actual). Primary completion is estimated for Jul 2027, 46 months after the start.
Of 274 non-industry observational studies under Renal Insufficiency, Chronic, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 192. This study's planned 46 months is below that.
Counting every sponsor, half of 325 studies reached it within 45 months; a quarter within 22 and three quarters within 191.
How these figures are worked out, and which studies are left out of them.
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