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Otsuka Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN)
||A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Immunoglobulin A Nephropathy
Chronic Kidney Disease, Proteinuria, Glomerular Disease, Kidney Diseases, Diabetic Kidney Problems, Diabetic Nephropathy
The purpose of this phase 3 trial is to see if the drug Sibeprenlimab is safe and effective in treating IgAN. We will look at whether the drug decreases the protein levels in your urine and delay kidney disease progression. If you qualify, you will receive either Sibeprenlimab or placebo for 100 weeks. We will then follow up with you for 8 weeks after after the final study drug treatment.
1. Age 18 years or older
2. Biopsy-confirmed diagnosis of the kidney disease IgAN within the past 8 years
1. History of organ transplantation
2. History of human immunodeficiency virus (HIV), hepatitis B (HBV) infection, or hepatitis C (HCV) infection
If you aren't sure if you qualify, please call us and we will help determine your eligibility.
If you qualify, you will receive either Sibeprenlimab or placebo for 100 weeks. We will then follow up with you for 8 weeks after after the final study drug treatment.