Open-label trial of Sibeprenlimab for treatment of IgAN
Research type
Research Study
Full title
A Phase 2/3, Multicenter, Open-label Trial to Evaluate the Long-term Safety, Tolerability, and Efficacy of Sibeprenlimab Administered Subcutaneously in Subjects with Immunoglobulin A Nephropathy
IRAS ID
1005870
Contact name
Jeffrey Hafkin
Contact email
Sponsor organisation
Otsuka Pharmaceutical Development & Commercialization, Inc.
Eudract number
2021-005526-17
Clinicaltrials.gov Identifier
Research summary
Immunoglobulin A nephropathy (IgAN) is a kidney disease that occurs when a protein called IgA builds up in the kidneys. This can result in inflammation which interferes with the kidneys’ ability to function properly and can lead to chronic kidney disease and ultimately kidney failure. IgAN is the most common cause of kidney failure in adults resulting in a high economic burden to the health care system when treating patients with end-stage kidney disease.
The cause of IgAN is unknown, although it can happen after an infection, and there is no cure for IgAN. Current treatments aim to slow down the process of kidney disease. Common problems of IgAN include high blood pressure and high cholesterol. Medicine to lower cholesterol/blood pressure, and supportive therapy such as good diet can help prevent further damage to the kidneys.
This is a rollover study; participants completing Trial 417-201-00007 or Trial VIS649-201 will be asked if they are interested in rolling over into this study in which sibeprenlimab is being assessed to determine the long-term safety and benefits when added to the participant’s prescribed standard of care treatment. Sibeprenlimab will be injected into the abdomen, thigh or upper arm every 4 weeks for approximately 2 years. During the study participants will undergo assessments which include physical examinations, blood and urine analysis, ECG and blood samples taken at specific timepoints to understand how the body responds to the study drug. Participants will also be asked to collect 24 hour urine samples during the study to review changes in levels of protein in the urine over the period of the study.
There is still a high unmet medical need for the development of effective treatments for IgAN. Sibeprenlimab is being studied and intended for chronic use to help delay or prevent kidney failure.REC name
East of England - Essex Research Ethics Committee
REC reference
22/EE/0153
Date of REC Opinion
22 Sep 2022
REC opinion
Further Information Favourable Opinion