Sibeprenlimab for IgA Nephropathy
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot be on systemic corticosteroids or immunosuppressants within 24 weeks before starting the trial. Other forms of corticosteroids like topical or inhaled are allowed.
What data supports the effectiveness of the drug Sibeprenlimab for IgA Nephropathy?
Research shows that Sibeprenlimab, a drug that blocks a protein called APRIL, can significantly reduce levels of certain antibodies (proteins made by the immune system) in the blood, which are involved in IgA Nephropathy. In studies with healthy participants, it was found to be safe and effectively lowered these antibodies in a dose-dependent manner, meaning higher doses led to greater reductions.12345
Is Sibeprenlimab safe for humans?
How is the drug Sibeprenlimab different from other drugs for IgA Nephropathy?
What is the purpose of this trial?
This is a phase 2b open-label trial to characterize histopathological biomarkers of disease in immunoglobulin A nephropathy (IgAN) and demonstrate potential changes in response to sibeprenlimab.
Eligibility Criteria
This trial is for individuals at least 16 years old with a confirmed diagnosis of IgA Nephropathy and a kidney function (eGFR) above 45 mL/min/1.73 m2. It's not for those with other chronic kidney diseases, low serum IgG levels, uncontrolled high blood pressure, pregnant or breastfeeding women, or anyone who has used systemic corticosteroids or immunosuppressants within the last 24 weeks.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive sibeprenlimab to evaluate its impact on kidney histopathology in IgAN
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Sibeprenlimab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Otsuka Pharmaceutical Development & Commercialization, Inc.
Lead Sponsor
John Kraus
Otsuka Pharmaceutical Development & Commercialization, Inc.
Chief Medical Officer since 2023
MD, PhD
Tarek Rabah
Otsuka Pharmaceutical Development & Commercialization, Inc.
Chief Executive Officer since 2022
BS in Biology and BA in Business from the American University of Beirut, MBA from McGill University