Belimumab in Idiopathic Membranous Glomerulonephropathy
Research type
Research Study
Full title
BEL116472. A 2 year mechanistic study of belimumab in Idiopathic Membranous Glomerulonephropathy
IRAS ID
103753
Contact name
Richard J D'Souza
Contact email
Eudract number
2012-000385-38
ISRCTN Number
n.a
Clinicaltrials.gov Identifier
n.a
Research summary
The purpose of this study is to test the safety and efficacy of belimumab, a monoclonal antibody in subjects with Idiopathic Membranous Glomerulonephropathy (IMGN). Idiopathic Membranous Glomerulonephropathy (IMGN) is an autoimmune disease; the immune system is overactive and attacks normal cells, causing kidney damage. Protein leaks through the kidneys into the urine. Belimumab is used to treat another autoimmune disease (Lupus). It is known to calm down the immune system and may help patients with IMGN. All study subjects will take belimumab for at least 6 months, whilst continuing to take their supportive treatment. Belimumab will be given by a 1 hour infusion into the veins every 2 weeks for the first month then 4-weekly until treatment is stopped. Some subjects may need to be treated every 2 weeks until improvement in the level of protein leak into the urine. Visits may take up to 4 hours or up to 6 hours for the first 2 infusion visits. After 6 months, if the subject??s condition is improved, they will stop belimumab and be followed up every 12 weeks. If it is not yet controlled at 6 months, they will continue treatment for up to 2 years. The study starts with a Screening Period of up to 35 days to see if subjects are eligible. This is followed by a Treatment Period and a Follow-Up Period, which together may run for up to 2 years 3 months. Tests/procedures include ?½ Physical examination , medical history, heart monitoring ?½ Blood tests to measure the amount of belimumab in the blood ?½ Vital signs: weight, height, blood pressure, temperature, pulse ?½ Blood tests to check general health, antibodies and other proteins which are markers of glomerulonephropathy ?½ Hepatitis B & C and HIV antibodies, pregnancy tests for women who can become pregnant ?½ Urine samples to test the amount of protein and belimumab ?½ Subject questionnaires
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
12/EE/0171
Date of REC Opinion
11 May 2012
REC opinion
Further Information Favourable Opinion