ClinicalTrials.gg
Not yet recruitingNCT07820995A-MECHUpdated Sep 21, 2026

Mechanistic Evaluation of Atrasentan in Patients With IgA Nephropathy (IgAN)

A Phase 4 interventional study of atrasentan in IgA Nephropathy (IgAN) and Immunoglobulin A Nephropathy (IgAN), sponsored by University of Illinois at Chicago. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by University of Illinois at Chicago · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This multicenter, single-arm, open-label Phase 4 pilot study evaluates the effects of atrasentan added to optimized supportive care on kidney structure and function in adults with biopsy-confirmed IgA nephropathy. Approximately 20 participants will receive atrasentan 0.75 mg orally once daily for 52 weeks. Kidney multiparametric MRI is performed at baseline, 6 months, and 12 months, with blood and urine biomarker assessments throughout treatment. An optional nested cohort of up to 5 participants undergoes native kidney biopsy at baseline and 12 months.

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Conditions studied

  • IgA Nephropathy (IgAN)
  • Immunoglobulin A Nephropathy (IgAN)

Keywords

  • IgA nephropathy
  • atrasentan
  • multiparametric MRI
  • MRI
  • biomarkers
  • kidney injury
  • mechanistic
  • fibrosis
  • renal blood flow
  • kidney biopsy
  • histopathology
03

In context

Glomerulonephritis, IGA

275 studies on the registry are indexed under Glomerulonephritis, IGA; 107 are open to participants now.

This study's planned enrollment of 20 is below the median of 62 across 221 interventional studies indexed under Glomerulonephritis, IGA.

Browse Glomerulonephritis, IGA studies →

Lead sponsor

University of Illinois at Chicago is the lead sponsor of 506 studies on the registry; 120 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.

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

04

Who can participate

Ages eligible
18 Years and older
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

  1. Signed .
  2. Male or female ≥18 years with -confirmed IgAN; ≥30 mL/min/1.73 m² for main cohort; >40 mL/min/1.73 m² for optional biopsy cohort.
  3. Screening UPCR ≥0.5 g/g measured by first morning void.
  4. Maximally tolerated or locally approved maximal ACEi/ARB dose before enrollment; diuretics, other antihypertensives and SGLT2i, if used, stabilized for at least 90 days before baseline.
  5. and sexually active participants must comply with protocol requirements.

Exclusion criteria

Exclusion Criteria:

  1. to study treatment/ or similar drug classes.
  2. CKD primarily attributable to non-IgAN etiology.
  3. Suspected RPGN or IgA vasculitis.
  4. Nephrotic syndrome.
  5. BNP >200 pg/mL or NT-proBNP >450 pg/mL at screening.
  6. \<80,000/µL.
  7. Organ transplant history other than corneal transplant.
  8. Systemic >2 weeks in prior 3 months or rituximab within 6 months.
  9. Confirmed BP >150/95 mmHg based on mean of 3 screening measurements.
  10. Heart failure/fluid overload.
  11. Significant liver disease or transaminases/ >2× .
  12. \<9 g/dL or transfusion for anemia within 3 months.
  13. unless protocol-defined exception.
  14. Pregnancy/breastfeeding or intent to become pregnant.
  15. Male intent to father a child/donate sperm during study and 1 month after.
  16. Recent /approved IgAN treatment per protocol washout.
  17. unstable/uncontrolled medical disorder that may confound results or add risk.
  18. Alcohol/illicit drug-related disorder within 3 years.
  19. not using highly effective ; sexually active males unwilling to use condoms.
  20. Prohibited therapies.
  21. MRI .
  22. Optional cohort exclusion if biopsy risk is unacceptably high.
Terms in these criteria, in plain language(16)

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.

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.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

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.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

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.

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.

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.

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).

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Atrasentan

    Adults with biopsy-confirmed IgAN receive atrasentan 0.75 mg orally once daily for 52 weeks in addition to optimized supportive care. The optional repeat-biopsy cohort is nested within this arm and is not a separate randomized arm.

    Drug: atrasentan

Interventions

  • Atrasentan 0.75 mg oral tablet once daily for 52 weeks, added to optimized supportive care.

    Also known as: vanrafia

06

What researchers measure

Primary outcomes

  1. Proportion of participants achieving improvement in at least one component of the composite kidney mpMRI endpoint at Month 6

    The proportion of participants with improvement from baseline at Month 6 in at least one of: ≥5% decrease in cortical native T1 mapping time; ≥5% increase in cortical apparent diffusion coefficient (ADC); or ≥10% increase in phase-contrast-derived renal artery blood flow.

    Time frame: Baseline to Month 6 (Week 26)

Secondary outcomes

  1. Percent change from baseline in urinary KIM-1 and MCP-1 over 6 months

    Percent change from baseline in urine biomarkers Kidney Injury Molecule-1 (KIM-1) and Monocyte Chemoattractant Protein-1 (MCP-1), assessed individually and/or as a composite.

    Time frame: Baseline through Month 6

Other outcomes

  1. Composite kidney mpMRI endpoint at Month 12

    Change from baseline in composite and individual imaging biomarkers; Month 12.

    Time frame: Baseline to month 12

  2. Imaging biomarker trajectory over 12 months

    Geometric mean percent change from baseline in composite and individual imaging biomarkers at Month 6 and Month 12.

    Time frame: Baseline to month 12

  3. Urine and blood biomarkers over 12 months

    Geometric mean percent change from baseline at Weeks 4, 12, 26 and 52.

    Time frame: Baseline to month 12

  4. Imaging biomarker slopes

    Change over time from baseline to Month 12 in T1 mapping, ADC and phase-contrast renal artery blood flow.

    Time frame: baseline to Month 12

  5. Urine/blood biomarker slopes

    Change over time from baseline to Month 12 in composite and individual biomarkers.

    Time frame: Baseline to Month 12

  6. Histopathology in biopsy cohort

    Change from baseline to Month 12 in MEST-C scoring and histopathologic staining in the nested repeat-biopsy cohort.

    Time frame: Baseline to Month 12

  7. Tissue expression profiles in biopsy cohort

    Change from baseline to Month 12 in regional proteomics, transcriptomics and single-cell/nucleus RNA sequencing expression profiles.

    Time frame: Baseline to Month 12

  8. Correlation with clinical kidney measures

    Correlation of changes in UPCR and eGFR with imaging and biochemical biomarker outcomes.

    Time frame: Baseline to month 12

07

Study locations

1 site
08

References and documents

Publications

  • Kidney Disease: Improving Global Outcomes (KDIGO) IgAV Work Group. (2025). KDIGO 2025 clinical practice guideline for the management of immunoglobulin A nephropathy (IgAN) and immunoglobulin A vasculitis (IgAV). Kidney International, 108(4), S1-S71. Kohan, D. E., Barratt, J., Heerspink, H. J., Campbell, K. N., Camargo, M., Ogbaa, I., ... & King, A. (2023). Targeting the endothelin A receptor in IgA nephropathy. Kidney International Reports, 8(11), 2198-2210. Kuo, J. J., Wu, J., Gunawan, M. G., McConnell, M. T., Lester, J., Naidu, N. A., ... & Cox, J. H. (2025). Effects of Atrasentan on Kidney Gene Transcription, Mesangial Cell Proliferation, and Proteinuria in Immunoglobulin A Nephropathy. Kidney360, 10-34067. Lai KN, Tang SCW, Schena FP, et al (2016) IgA nephropathy. Nat Rev Dis Primers 2:16001. Lim, R. S., Yeo, S. C., Barratt, J., & Rizk, D. V. (2024). An update on current therapeutic options in IgA nephropathy. Journal of Clinical Medicine, 13(4), 947. Noronha, I. L., Barratt, J., Gorriz, J. L., Kotwal, S., Lim, S. K., Beckett, V., ... & Heerspink, H. J. (2024). WCN24-1868 ASSIST: A randomized double-blind, placebo controlled crossover trial of atrasentan in patients with IgA nephropathy (IgAN) on SGLT2i. Kidney International Reports, 9(4), S178. Peters, H. P. E., Waanders, F., Meijer, E., van den Brand, J. A. J. G., Steenbergen, E. J., van Goor, H., & Wetzels, J. F. M. (2011). High urinary excretion of kidney injury molecule-1 is an independent predictor of end-stage renal disease in patients with IgA nephropathy. Nephrology Dialysis Transplantation, 26(11), 3581-3588. Suzuki Y, Monteiro RC, Coppo R, et al (2021) The Phenotypic Difference of IgA Nephropathy and its Race/Gender-dependent Molecular Mechanisms. Kidney360; 2(8):1339- 1348. Torres, D. D., Rossini, M., Manno, C., Mattace-Raso, F. U. S., D'Altri, C., Ranieri, E., Pontrelli, P., Grandaliano, G., & Schena, F. P. (2008). The ratio of epidermal growth factor to monocyte chemotactic peptide-1 in the urine p
  • Barratt, J., Kim, S. G., Inker, L. A., Packham, D. K., Ranganathan, D., Rheault, M. N., ... & Han, S. H. (2025). WCN25-778 AFFINITY study: 1-year results of atrasentan in IgA nephropathy (IgAN). Kidney International Reports, 10(2), S183. Boels, M. G., Avramut, M. C., Koudijs, A., Dane, M. J., Lee, D. H., Van Der Vlag, J., ... & Rabelink, T. J. (2016). Atrasentan reduces albuminuria by restoring the glomerular endothelial glycocalyx barrier in diabetic nephropathy. Diabetes, 65(8), 2429-2439. Buchanan, C.E.; Mahmoud, H.; Cox, E.F.; Prestwich, B.L.; Noble, R.A.; Selby, N.M.; Taal, M.W.; Francis, S.T. Multiparametric Renal Magnetic Resonance Imaging for Prediction and Annual Monitoring of the Progression of Chronic Kidney Disease over Two Years. J. Clin. Med. 2023, 12, 7282. Francis, S. T., Selby, N. M., and Taal, M. W. Magnetic Resonance Imaging to Evaluate Kidney Structure, Function, and Pathology: Moving Toward Clinical Application Am J Kidney Dis. 82(4):491-504. Heerspink, H. J., Jardine, M., Kohan, D. E., Lafayette, R. A., Levin, A., Liew, A., ... & Renfurm, R. (2025). Atrasentan in patients with IgA nephropathy. N Engl J Med, 392(6), 544-554. Heerspink, H. J., Kohan, D. E., & de Zeeuw, D. (2021). New insights from SONAR indicate adding sodium glucose co-transporter 2 inhibitors to an endothelin receptor antagonist mitigates fluid retention and enhances albuminuria reduction. Kidney International, 99(2), 346-349. Heerspink, H. J. Noronha, I. L, Górriz, J. L., Lim, S. K., Kotwal, Sradha S.,…&; Mottl, A. K. . (2026). Efficacy and Safety of Atrasentan in Patients with IgA Nephropathy Receiving Sodium-Glucose Cotransporter 2 Inhibitors: Placebo-Controlled, Crossover Trial. JASN. Heerspink, H. J., Parving, H. H., Andress, D. L., Bakris, G., Correa-Rotter, R., Hou, F. F., ... & Bieler, T. (2019). Atrasentan and renal events in patients with type 2 diabetes and chronic kidney disease (SONAR): a double-blind, randomised, placebo-controlled trial. The Lancet, 393(10184),

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Dec 2027, 15 months later.

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

Registered
Sep 9, 2026
First posted
Sep 15, 2026
StartEst.
Sep 29, 2026
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2028
Last update
Sep 21, 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.
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07820995
Responsible party
Sponsor
First posted
Sep 15, 2026
Start date
Sep 29, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Sep 21, 2026

Study contacts

Kimberly Silva, MPH
Contact
ksilva4@uic.edu
312-996-0185
Natalie Meza, MPH
Contact
nmeza1@uic.edu
3129966033
Anand Srivastava, MD, MPH
principal investigator · University of Illinois at Chicago

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 Sep 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Atrasentan

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