Proof of Concept Study of BHV-1400 in IgA Nephropathy
Research type
Research Study
Full title
An Open-Label Biomarker Study of BHV1400 in IgA Nephropathy
IRAS ID
1012167
Contact name
Tova Gardin
Contact email
Sponsor organisation
Biohaven Therapeutics Ltd c/o Biohaven Pharmaceuticals, Inc.
Clinicaltrials.gov Identifier
Research summary
IgA nephropathy (IgAN) is a kidney disease that happens when a harmful type of antibody, called Gd-IgA1, builds up in the blood. The body mistakenly attacks it, forming clumps that settle in the kidneys and cause inflammation and scarring. Over time, this can lead to kidney damage and even kidney failure. Until recently, treatment for IgAN mainly focused on general care, not on directly treating the disease itself. Newer treatments have been approved that either weaken the immune system (like budesonide), block parts of the immune response (like Iptacopan), or manage the effects of kidney damage (like Sparsentan). However, none of these treatments specifically target the root cause of the disease — the harmful Gd-IgA1 antibody — without also weakening the body’s overall immune defences.
A new drug, BHV-1400, is being developed to remove Gd-IgA1 by sending it to the liver to be safely broken down. It does this without affecting other important antibodies, helping protect the body's ability to fight infections. This proposed study (called BHV1400-102) is now being done to test this drug in people who have been diagnosed with IgA nephropathy (IgAN) through a kidney biopsy.
About 10 participants will receive multiple dosed of BHV-1400, and researchers will monitor how safe and well-tolerated it is, how the body processes the drug, and how it affects Gd-IgA1 levels.
The study will consist of a screening period that may last up to 28 days, a treatment phase of 29 days and follow up phase through day 60. The study team may adjust the dose or schedule based on safety and drug response data.REC name
South Central - Oxford C Research Ethics Committee
REC reference
25/SC/0269
Date of REC Opinion
2 Oct 2025
REC opinion
Further Information Favourable Opinion