Recruiting NCT07054684
Study of BHV-1400 in IgA Nephropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BHV-1400.
- Who it may be relevant to
- Registry conditions: IgA Nephropathy. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-Label Biomarker Study of BHV-1400 in IgA Nephropathy
Overview
The purpose of this study is to determine if BHV-1400 is a safe and tolerable treatment in participants with IgA Nephropathy (IgAN).
Interventions
- Drug BHV-1400
BHV-1400 is delivered subcutaneously (SC)
Primary outcome measures
- Number of participants with Serious AEs (SAEs), AEs leading to discontinuation, deaths [Time frame: Up to 1 year]
- Number of participants with Grade 3-4 treatment-emergent laboratory abnormalities [Time frame: Up to 1 year]
Eligibility criteria
Inclusion criteria
1\. Participants must have biopsy-confirmed IgA Nephropathy
Exclusion criteria
- Any secondary IgAN
- Any cause of chronic kidney disease not diagnosed as IgAN or due to non-IgAN cause
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 14 centers
- Site-001 — Farmington
- Site-003 — Miami Lakes
- Site-011 — Miami Lakes
- Site-013 — Orlando
- Site-005 — Pembroke Pines
- Site-008 — Lawrenceville
- Site-009 — Hinsdale
- Site-012 — Indianapolis
- … and 6 more centers
United Kingdom · 1 center
- Site-007 — Leicester
Identifiers
NCT: NCT07054684 · BHV1400-102