IgA Nephropathy
Conditions
Keywords
IgAN, proteinuria, glomerulonephropathy, chronic kidney disease, kidney disease, CKD, nephritis, urologic disease, glomerulonephritis, Glomerular disease, Iga nephropathy, renal disease
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).
Interventions
DRUGBHV-1400
BHV-1400 is delivered subcutaneously (SC)
Sponsors
Biohaven Therapeutics Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Serious AEs (SAEs), AEs leading to discontinuation, deaths | Up to 1 year | 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 | Up to 1 year | 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. |
Countries
United Kingdom, United States
Contacts
CONTACTChief Medical Officer
Outcome results
None listed