BHV-1400 for IgA nephropathy
An Open-Label Biomarker Study of BHV-1400 in IgA Nephropathy
This study will try BHV-1400 in adults with biopsy-confirmed IgA nephropathy to see if the drug is safe and tolerable.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Biohaven Pharmaceuticals, Inc. Industry-sponsored |
| Locations | 12 sites (Farmington, Connecticut and 11 other locations) |
| Trial ID | NCT07054684 on ClinicalTrials.gov |
What this trial studies
This Phase 1 interventional trial tests the safety and tolerability of BHV-1400 in participants with biopsy-confirmed IgA nephropathy. Enrolled participants will receive BHV-1400 and undergo regular clinical and laboratory monitoring for adverse events, kidney function, and measures such as proteinuria. The trial specifically excludes secondary IgAN and other non-IgAN causes of chronic kidney disease to focus on primary IgAN. The study is being conducted at multiple U.S. sites in Connecticut and Florida.
Who should consider this trial
Good fit: Adults with biopsy-confirmed primary IgA nephropathy who meet the study's health criteria and can attend visits at a participating site are the intended candidates.
Not a fit: People with secondary IgA nephropathy or chronic kidney disease caused by non-IgAN conditions are excluded and would not be expected to benefit from this study.
Why it matters
Potential benefit: If successful, BHV-1400 could provide a new, well-tolerated treatment option that reduces proteinuria and helps slow kidney damage in people with IgA nephropathy.
How similar studies have performed: Some other targeted therapies for IgA nephropathy have shown promise in reducing proteinuria in later-phase trials, but BHV-1400 is a novel agent and its safety and effectiveness in IgAN remain unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: 1\. Participants must have biopsy-confirmed IgA Nephropathy Key Exclusion Criteria: 1. Any secondary IgAN 2. Any cause of chronic kidney disease not diagnosed as IgAN or due to non-IgAN cause
Where this trial is running
Farmington, Connecticut and 11 other locations
- Site-001 — Farmington, Connecticut, United States (Recruiting)
- Site-003 — Miami Lakes, Florida, United States (Recruiting)
- Site-011 — Miami Lakes, Florida, United States (Recruiting)
- Site-013 — Orlando, Florida, United States (Recruiting)
- Site-005 — Pembroke Pines, Florida, United States (Recruiting)
- Site-008 — Lawrenceville, Georgia, United States (Recruiting)
- Site-009 — Hinsdale, Illinois, United States (Recruiting)
- Site-012 — Indianapolis, Indiana, United States (Recruiting)
- Site-006 — Chesterfield, Missouri, United States (Recruiting)
- Site-002 — Dakota Dunes, South Dakota, United States (Recruiting)
- Site-004 — Houston, Texas, United States (Recruiting)
- Site-007 — Leicester, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Chief Medical Officer
- Email: clinicaltrials@biohavenpharma.com
- Phone: 203-404-0410
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.