Study of BHV-1400 in IgA Nephropathy
- Registration Number
- NCT07054684
- Lead Sponsor
- Biohaven Therapeutics Ltd.
- Brief Summary
The purpose of this study is to determine if BHV-1400 is a safe and tolerable treatment in participants with IgA Nephropathy (IgAN).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
1. Participants must have biopsy-confirmed IgA Nephropathy
Key
- Any secondary IgAN
- Any cause of chronic kidney disease not diagnosed as IgAN or due to non-IgAN cause
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BHV-1400 BHV-1400 -
- Primary Outcome Measures
Name Time Method Number of participants with Serious AEs (SAEs), AEs leading to discontinuation, deaths Baseline to Day 29 To assess the safety and tolerability of BHV-1400. This objective will be measured by assessing the number of unique subjects with SAEs, moderate or severe AEs, AEs leading to discontinuation or deaths
Number of participants with Grade 3-4 treatment-emergent laboratory abnormalities Baseline to Day 29 To assess the safety and tolerability of BHV-1400. This objective will be measured by assessing the number of unique subjects with Grade 3 or 4 treatment-emergent laboratory abnormalities.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Site-009
🇺🇸Hinsdale, Illinois, United States
Site-003
🇺🇸Miami Lakes, Florida, United States
Site-005
🇺🇸Pembroke Pines, Florida, United States
Site-006
🇺🇸Chesterfield, Missouri, United States
Site-002
🇺🇸Dakota Dunes, South Dakota, United States
Site-004
🇺🇸Houston, Texas, United States
Site-009🇺🇸Hinsdale, Illinois, United States