BHV-1400 for IgA Nephropathy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called BHV-1400 to determine its safety and tolerability for people with IgA Nephropathy (IgAN), a kidney disease. IgAN can damage the kidneys, causing blood or protein in the urine and swelling. The trial aims to understand how individuals with biopsy-confirmed IgAN respond to this treatment. It suits those diagnosed with IgAN and no other kidney conditions. As a Phase 1 trial, the research seeks to understand how the treatment works in people, offering participants the chance to be among the first to receive it.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that BHV-1400 is likely to be safe for humans?
Research has shown that BHV-1400 is being developed to help the body naturally remove certain proteins that can lead to kidney issues. This treatment remains in the early testing phase for individuals with IgA Nephropathy (IgAN), a type of kidney disease. As a new treatment in the first phase of testing, detailed safety information in humans is not yet available.
Early trials like this aim to determine the treatment's safety, so researchers will closely monitor any side effects or negative reactions. Participants in the trial will be observed carefully to assess their response to BHV-1400 and identify any unwanted effects. If deemed safe, the treatment can advance to later testing stages with more participants.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for IgA nephropathy, which typically involve medications like corticosteroids or immunosuppressants to reduce inflammation, BHV-1400 offers a new approach. Researchers are excited about BHV-1400 because it targets the underlying causes of the disease differently. While traditional options focus on dampening the immune response, BHV-1400 may work by specifically modulating pathways involved in the formation of IgA deposits, potentially reducing kidney damage more effectively. This novel mechanism of action gives hope for more efficient and precise treatment, possibly leading to better outcomes for patients.
What evidence suggests that BHV-1400 might be an effective treatment for IgA Nephropathy?
Research has shown that BHV-1400, the investigational treatment in this trial, may help treat IgA Nephropathy (IgAN). Studies have found that this treatment can quickly and significantly lower levels of the harmful protein Gd-IgA1, which plays a major role in IgAN. This decrease occurs rapidly and lasts, which is crucial for long-term management of the condition. Evidence supports that BHV-1400 effectively targets and reduces harmful proteins in the blood and kidneys, key areas affected by IgAN. These early results suggest that BHV-1400 could effectively manage IgAN symptoms and slow its progression.12346
Are You a Good Fit for This Trial?
This trial is for individuals who have been diagnosed with IgA Nephropathy (IgAN) through a kidney biopsy. It's not open to people whose chronic kidney disease isn't caused by IgAN or those with secondary forms of the condition.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BHV-1400 to assess safety and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BHV-1400
Find a Clinic Near You
Who Is Running the Clinical Trial?
Biohaven Therapeutics Ltd.
Lead Sponsor