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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT07820995
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Sep 15, 2026
Start date
Sep 29, 2026
Status verified
Sep 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Illinois ChicagoChicagoIllinois60612
Anand Srivastava, MD, MPH
[email protected]
312-355-0627
Kimberly Silva, MPH
[email protected]
312-996-0185
Anand Srivastava, MD, MPH (PRINCIPAL_INVESTIGATOR)

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