Can a daily pill protect kidneys in IgA nephropathy? MRI study puts atrasentan to the test

NCT ID NCT07820995

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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The full record has not been published yet, so there is little to show here.
Status unknown
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First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Researchers are testing whether adding atrasentan to standard supportive care improves kidney structure and function in adults with IgA nephropathy, a condition where the immune system damages the kidneys. About 20 participants will take atrasentan 0.75 mg once daily for 52 weeks. The study uses specialized kidney MRI scans at the start, 6 months, and 12 months, along with blood and urine tests, to see if the drug changes kidney tissue and blood flow. A small optional group will also have kidney biopsies at the start and after 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
atrasentan, an oral drug that blocks endothelin receptors
What this could lead to
If it works, atrasentan could become a way to slow kidney damage in IgA nephropathy and delay the need for dialysis. The MRI and biopsy measures could also give doctors better tools to track kidney health.
What could go wrong
This is a small, single-arm pilot study with about 20 people and no comparison group, so any changes seen may not be due to the drug. Atrasentan can cause fluid retention and other side effects, and the trial may not show clear benefit on kidney structure or function.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Signed informed consent. 2. 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. 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. WOCBP and sexually active participants must comply with protocol contraception requirements. Exclusion Criteria: 1. Hypersensitivity to study treatment/excipients 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. Platelets \<80,000/µL. 7. Organ transplant history other than corneal transplant. 8. Systemic immunosuppressants \>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/bilirubin \>2× ULN. 12. Hemoglobin \<9 g/dL or transfusion for anemia within 3 months. 13. Malignancy 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 investigational/approved IgAN treatment per protocol washout. 17. Clinically significant unstable/uncontrolled medical disorder that may confound results or add risk. 18. Alcohol/illicit drug-related disorder within 3 years. 19. WOCBP not using highly effective contraception; sexually active males unwilling to use condoms. 20. Prohibited therapies. 21. MRI contraindications. 22. Optional biopsy cohort exclusion if biopsy risk is unacceptably high.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • University of Illinois Chicago

    Chicago, Illinois, 60612, United States

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