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

Study acronym: A-MECH
StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fields
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07820995
Lead Sponsor University of Illinois at Chicago
Collaborators: Novartis, University of Michigan, Endeavor Health, University of North Carolina, Chapel Hill, Icahn School of Medicine at Mount Sinai
Conditions IgA Nephropathy (IgAN), Immunoglobulin A Nephropathy (IgAN)
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov