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Otsuka Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN)
| Title |
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 |
| Therapeutic Area |
Chronic Kidney Disease, Proteinuria, Glomerular Disease, Kidney Diseases, Diabetic Kidney Problems, Diabetic Nephropathy
|
| Principal Investigator |
Lesley Inker |
| Min Age |
18 Years |
| Gender |
Any |
| Contact |
617-636-9423
kidneytrials@tuftsmedicalcenter.org
|
| More Information |
https://clinicaltrials.gov/ct2/show/NCT05248646 |
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.
Inclusion Criteria
1. Age 18 years or older
2. Biopsy-confirmed diagnosis of the kidney disease IgAN within the past 8 years
Exclusion Criteria
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.
Study Requirements
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.
