VISIONARY STUDY:Phase 3 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy (IgAN)
Research type
Research Study
Full 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
IRAS ID
1005054
Contact name
Karen Ruker
Contact email
Sponsor organisation
Otsuka Pharmaceutical Development & Commercialization, Inc.
Eudract number
2022-000814-32
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. There is still a high unmet medical need for the development of effective treatments for IgAN.
In this study, sibeprenlimab is being assessed with a placebo (a substance that looks the same but with no active drug) to determine its safety and benefits when added to the participant’s prescribed standard of care treatment. Participants will be randomly assigned 50/50 (like flipping a coin), to receive sibeprenlimab or placebo, added to their standard of care. Sibeprenlimab or placebo 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 on 4 separate occasions during the study to review changes in the levels of protein in the urine over the period of the study.
At the end of this study, participants may have the opportunity to enter an open-label extension study where all participants will receive sibeprenlimab.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
22/EM/0175
Date of REC Opinion
13 Sep 2022
REC opinion
Further Information Favourable Opinion