Efficacy and Safety of Belimumab in the Treatment of IgA Nephropathy
Research type
Research Study
Full title
A Phase 2 Placebo-controlled Double Blinded Study to Assess the Efficacy and Safety of Intravenous Infusion with Belimumab in Subjects with Immunoglobulin A Nephropathy (IgAN)
IRAS ID
237774
Contact name
Chee Kay Cheung
Contact email
Sponsor organisation
University of Leicester
Eudract number
2017-004366-10
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
IgA nephropathy (IgAN) is a kidney disease that occurs when an antibody called immunoglobulin A (IgA) lodges in the kidneys. When this happens, local inflammation may then occur that causes the kidneys to leak blood and protein, and over time, may hamper the kidneys’ ability to filter waste from the blood. Approximately 25% of IgAN patients develop hypertension and protein in the urine (proteinuria). Many then develop end stage renal disease (ESRD) within 10 years.
There is currently no cure for IgAN. The goal of IgAN treatment presently is to prevent or delay ESRD. Treatment of IgAN has not changed significantly during the last three decades and effective, approved therapy is lacking. Guidelines recommend therapy based on angiotensin converting enzyme inhibitor (ACEis) or angiotensin receptor blocker (ARBs) with or without medicines to suppress the immune system (steroids, cytotoxic agents), for blood pressure control and proteinuria reduction. However, immunosuppressive medications currently used (including steroids), have considerable side-effects and are only moderately effective in treating IgAN.
Belimumab is a drug that blocks the survival signals needed for cells to produce the IgA and other antibodies that are lodged on the kidneys in IgAN. In doing so, this may help to stop the disease process.
The purpose of this study is to find out if belimumab is safe, can reduce IgA and other antibody formation, can reduce proteinuria and improve kidney function in IgAN.
The study will run for around 2 years, and will enrol a maximum of 21 patients. Participants will visit the study doctor 15 times over the first year for assessments, monitoring of their condition, and infusions of the active drug or placebo into the veins. They will visit the study doctor 4-5 times over the second year for monitoring to see if any beneficial effects of the drug are sustained.
No participants were recruited.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
19/EM/0070
Date of REC Opinion
24 May 2019
REC opinion
Further Information Favourable Opinion