BHV-1400 for IgA nephropathy
Official title: An Open-Label Biomarker Study of BHV-1400 in IgA Nephropathy
Run by Biohaven Pharmaceuticals, Inc. · NCT07054684 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Biohaven Pharmaceuticals, Inc. Industry-sponsored |
| Locations | 15 sites (Farmington, Connecticut and 14 other locations) |
| Status | Recruiting |
| Started | July 30, 2025 |
| Main results expected | July 2027 |
| Study ends | July 2027 |
| Registry record updated | June 23, 2026 |
| Trial ID | NCT07054684 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Show 9 more locations
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Site-009
Hinsdale, Illinois, United States Recruiting -
Site-012
Indianapolis, Indiana, United States Recruiting -
Site-015
Shelby, Michigan, United States Recruiting -
Site-006
Chesterfield, Missouri, United States Recruiting -
Site-002
Dakota Dunes, South Dakota, United States Recruiting -
Site-014
Houston, Texas, United States Recruiting -
Site-004
Houston, Texas, United States Recruiting -
Site-016
Salt Lake City, Utah, United States Recruiting -
Site-007
Leicester, United Kingdom Recruiting
Study contacts
- Study coordinator: Chief Medical Officer
- Email: clinicaltrials@biohavenpharma.com
- Phone: 203-404-0410
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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JADE101 in IgA Nephropathy: a Phase 2 test in adults
This Phase 2 open-label study tests JADE101 in adults with IgA nephropathy to see how safe it is and how well it works when added to standard care.
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Atrasentan for pediatric primary IgA nephropathy
This study tests whether atrasentan can help children and teens with primary IgA nephropathy reduce protein in urine.
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Anti-CD19/BCMA universal CAR-T (RD06-05) for autoimmune diseases
This early-phase test gives a universal CAR-T therapy (RD06-05) that targets CD19 and BCMA to adults with autoimmune diseases such as SLE/lupus nephritis, ANCA-associated vasculitis, and anti-GBM disease.
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Nefecon (budesonide) plus ambrisentan for IgA nephropathy with proteinuria
This test will see if combining Nefecon (a gut‑targeted budesonide) with ambrisentan can reduce urine protein and slow kidney decline in adults with IgA nephropathy who have at least 0.5 g of protein in a 24‑hour urine collection.
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Epithelial Dysmetabolism and Kidney Fibrosis in ANCA Vasculitis
This study tests whether alterations in tubulo-interstitial metabolism relate to how quickly kidney function deteriorates in people with ANCA-associated vasculitis compared to other nephropathies.
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Which approved add-on drugs slow kidney decline in South-Asian adults with biopsy-proven IgA nephropathy?
This trial will test whether adding one of several approved oral medications to standard care can slow kidney function loss over two years in South-Asian adults with biopsy-proven IgA nephropathy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.