Study of BHV-1400 in IgA Nephropathy

Not Applicable

Not yet recruiting

• Conditions: IgA Nephropathy
• Interventions: Drug: BHV-1400

• 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 participantswith IgA Nephropathy (IgAN).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-27
• Study First Submitted QC: 2025-06-27
• Last Update Submitted: 2025-06-27
• Study Start: 2025-07-01
• Study First Posted: 2025-07-08
• Last Update Posted: 2025-07-08
• Primary Completion: 2026-07
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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

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.