Atrasentan for Berger's Disease
(A-MECH Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Anand Srivastava, MD, MPH
Principal Investigator
University of Illinois at Chicago
Are You a Good Fit for This Trial?
This trial is for adults diagnosed with IgA nephropathy (Berger's Disease) confirmed by a kidney biopsy. Participants should already be receiving the best available supportive care for their condition.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Atrasentan
Trial Overview
The study tests atrasentan, taken as a daily pill for one year, to see how it affects kidney structure and function in people with IgA nephropathy. All participants receive the drug alongside standard care; there is no placebo group.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Illinois at Chicago
Lead Sponsor
Novartis
Industry Sponsor
Vasant Narasimhan
Novartis
Chief Executive Officer since 2018
MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government
Shreeram Aradhye
Novartis
Chief Medical Officer since 2022
MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania
University of Michigan
Collaborator
Endeavor Health
Collaborator
University of North Carolina, Chapel Hill
Collaborator
Icahn School of Medicine at Mount Sinai
Collaborator
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