NCT07820995Not yet recruitingPhase 4
Mechanistic Evaluation of Atrasentan in Patients With IgA Nephropathy (IgAN)
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)
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 9 Sept 2026
- Start date
- 29 Sept 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- University of Illinois Chicago
- Diseases
- IgA nephropathy
- NCT number
- NCT07820995
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 20
- From 29 Sept 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- Platelets \<80,000/µL.
- Significant liver disease or transaminases/bilirubin \>2× ULN.
- Hemoglobin \<9 g/dL or transfusion for anemia within 3 months.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Illinois Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.