University of Illinois at Chicago
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.
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/e…
Atrasentan 0.75 mg oral tablet once daily for 52 weeks, added to optimized supportive care.
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