IgA Nephropathy (IgAN)Phase 4A-MECHNCT07820995
Mechanistic Evaluation of Atrasentan in Patients With IgA Nephropathy (IgAN)
A Phase 4 study testing atrasentan in people with IgA Nephropathy (IgAN) and Immunoglobulin A Nephropathy (IgAN), run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IgA Nephropathy (IgAN), Immunoglobulin A Nephropathy (IgAN)
- What is being tested?
- atrasentan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2026to 31 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent.
- Male or female ≥18 years with biopsy-confirmed IgAN; eGFR ≥30 mL/min/1.73 m² for main cohort; >40 mL/min/1.73 m² for optional biopsy cohort.
- Screening UPCR ≥0.5 g/g measured by first morning void.
- 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.
- WOCBP and sexually active participants must comply with protocol contraception requirements.
Who cannot join
- Hypersensitivity to study treatment/excipients or similar drug classes.
- CKD primarily attributable to non-IgAN etiology.
- Suspected RPGN or IgA vasculitis.
- Nephrotic syndrome.
- BNP >200 pg/mL or NT-proBNP >450 pg/mL at screening.
- Platelets <80,000/µL.
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- Organ transplant history other than corneal transplant.
- Systemic immunosuppressants >2 weeks in prior 3 months or rituximab within 6 months.
- Confirmed BP >150/95 mmHg based on mean of 3 screening measurements.
- Heart failure/fluid overload.
- Significant liver disease or transaminases/bilirubin >2× ULN.
- Hemoglobin <9 g/dL or transfusion for anemia within 3 months.
- Malignancy unless protocol-defined exception.
- Pregnancy/breastfeeding or intent to become pregnant.
- Male intent to father a child/donate sperm during study and 1 month after.
- Recent investigational/approved IgAN treatment per protocol washout.
- Clinically significant unstable/uncontrolled medical disorder that may confound results or add risk.
- Alcohol/illicit drug-related disorder within 3 years.
- WOCBP not using highly effective contraception; sexually active males unwilling to use condoms.
- Prohibited therapies.
- MRI contraindications.
- Optional biopsy cohort exclusion if biopsy risk is unacceptably high.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Illinois Chicago
Chicago, Illinois, 60612
Anand Srivastava, MD, MPH, 312-355-0627, asrivast@uic.edu
Kimberly Silva, MPH, 312-996-0185, ksilva4@uic.edu
About this study
Official title: A Multicenter, Single Arm, Open Label, Pilot Study to Assess the Effect of Atrasentan Alongside Supportive Care on Structural and Functional Changes in Kidneys of Adult Patients With IgA Nephropathy (IgAN)
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.
- Being tested
- atrasentan
- Keywords
- IgA nephropathy, atrasentan, multiparametric MRI, MRI, biomarkers, kidney injury, mechanistic, fibrosis, renal blood flow, kidney biopsy, histopathology
- Medical subject headings
- Glomerulonephritis, IGA, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atrasentanDrug
Also called vanrafia
Atrasentan 0.75 mg oral tablet once daily for 52 weeks, added to optimized supportive care.
| Study group | Role | What they receive |
|---|---|---|
| Atrasentan | Experimental | 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. Receives: Drug: atrasentan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline through Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start29 Sep 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for IgA Nephropathy (IgAN)Studies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis, University of Michigan, Endeavor Health, University of North Carolina, Chapel Hill, Icahn School of Medicine at Mount Sinai
- Responsible party
- Sponsor
- Investigators
- Anand Srivastava, MD, MPH, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820995
- Sponsor's protocol ID
- CEXV811A1US01R
- Other IDs
- 2026-0496
- Acronym
- A-MECH
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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),
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single Arm, Open Label, Pilot Study to Assess the Effect of Atrasentan Alongside Supportive Care on Structural and Functional Changes in Kidneys of Adult Patients With IgA Nephropathy (IgAN)
- ClinicalTrials.gov ID
- NCT07820995
- Acronym / sponsor ID
- A-MECH / CEXV811A1US01R
- Keywords
- IgA nephropathy, atrasentan, multiparametric MRI, MRI, biomarkers, kidney injury, mechanistic, fibrosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Novartis, University of Michigan, Endeavor Health, University of North Carolina, Chapel Hill, Icahn School of Medicine at Mount Sinai
- Study start
- 29 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atrasentan | Experimental | Drug: atrasentanAdults 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent.
- Male or female ≥18 years with biopsy-confirmed IgAN; eGFR ≥30 mL/min/1.73 m² for main cohort; >40 mL/min/1.73 m² for optional biopsy cohort.
- Screening UPCR ≥0.5 g/g measured by first morning void.
- 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.
- WOCBP and sexually active participants must comply with protocol contraception requirements.
Key exclusion criteria (22 listed)
- Hypersensitivity to study treatment/excipients or similar drug classes.
- CKD primarily attributable to non-IgAN etiology.
- Suspected RPGN or IgA vasculitis.
- Nephrotic syndrome.
- BNP >200 pg/mL or NT-proBNP >450 pg/mL at screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| atrasentanAlso: vanrafiaAtrasentan 0.75 mg oral tablet once daily for 52 weeks, added to optimized supportive care. | Drug | Atrasentan |
Primary outcome
Proportion of participants achieving improvement in at least one component of the composite kidney mpMRI endpoint at Month 6
Time frame: Baseline to Month 6 (Week 26)
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.
1 secondary outcome
Percent change from baseline in urinary KIM-1 and MCP-1 over 6 months
Time frame: Baseline through Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- BackgroundKidney 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
- BackgroundBarratt, 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 dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anand Srivastava, MD, MPH principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing atrasentan in people with IgA Nephropathy (IgAN) and Immunoglobulin A Nephropathy (IgAN), run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kimberly Silva, MPH (312-996-0185, ksilva4@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving improvement in at least one component of the composite kidney mpMRI endpoint at Month 6 (time frame: Baseline to Month 6 (Week 26)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07820995, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.