Studies the effect of atrasentan on kidneys in IgA nephropathy
Tests atrasentan, added to usual care, in adults with IgA nephropathy.
Plain-language title generated from the registry record
Registry title: Mechanistic Evaluation of Atrasentan in Patients With IgA Nephropathy (IgAN)
Key facts
- Where
- Chicago, United StatesSee the site
- Phase
- Phase 4
Where in United States
- University of Illinois ChicagoChicago, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Illinois Chicago
- Trial code
- NCT07820995
- Record updated
- 21 September 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Organ transplant history other than corneal transplant; Systemic immunosuppressants >2 weeks in prior 3 months or rituximab within 6 months; Recent investigational/approved IgAN treatment per protocol washout; Prohibited therapies; Hypersensitivity to study treatment/excipients or similar drug classes; Nephrotic syndrome; Heart failure/fluid overload; Malignancy unless protocol-defined exception; Clinically significant unstable/uncontrolled medical disorder that may confound results or add risk; Alcohol/illicit drug-related disorder within 3 years; Platelets <80,000/µL; Significant liver disease or transaminases/bilirubin >2× ULN; Hemoglobin <9 g/dL or transfusion for anemia within 3 months; CKD primarily attributable to non-IgAN etiology; Suspected RPGN or IgA vasculitis; BNP >200 pg/mL or NT-proBNP >450 pg/mL at screening; Confirmed BP >150/95 mmHg based on mean of 3 screening measurements; Pregnancy/breastfeeding or intent to become pregnant; Male intent to father a child/donate sperm during study and 1 month after; WOCBP not using highly effective contraception; sexually active males unwilling to use condoms; MRI contraindications; Optional biopsy cohort exclusion if biopsy risk is unacceptably high.