PROTECT 021IGAN17001
Research type
Research Study
Full title
A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PARALLEL-GROUP, ACTIVE-CONTROL STUDY OF THE EFFICACY AND SAFETY OF SPARSENTAN FOR THE TREATMENT OF IMMUNOGLOBULIN A NEPHROPATHY
IRAS ID
250101
Contact name
Jonathan Barratt
Contact email
Sponsor organisation
Retrophin , Inc.
Eudract number
2017-004605-41
Duration of Study in the UK
2 years, 3 months, 1 days
Research summary
This is a Phase 3 study in patients with IgAN (Immunoglobulin A Nephropathy). IgAN is a condition that results in kidney inflammation that, over time, may decrease the kidneys' ability to filter wastes from the blood. Participants who are eligible for the study will be randomly assigned to receive either sparsentan or active control (Irbesartan). Eligible participants will undertake a number of study visits, at approximately 12-week intervals for a variety of tests and treatment with the study medication (which is a capsule). This study is being conducted to determine if the drug, sparsentan, is safe and effective in lowering the amount of protein in the urine. In this study, sparsentan will be compared to the drug Irbesartan, which is approved by the United States FDA and the European Union, and some other countries worldwide to treat high blood pressure and kidney disease caused by diabetes.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
18/EM/0229
Date of REC Opinion
4 Oct 2018
REC opinion
Further Information Favourable Opinion