A 2 year study to investigate belimumab in membranous nephropathy

• Research type

  Research Study

• Full title

  BEL114674: A 2 year study of efficacy and safety of intravenous belimumab versus placebo in subjects with idiopathic membranous nephropathy

• IRAS ID

  110357

• Contact name

  Alan Salama

• Sponsor organisation

  GlaxoSmithKline UK Ltd

• Eudract number

  2011-000242-38

• ISRCTN Number

  not issued

• Research summary

  The purpose of this study is to test the safety and the efficacy of belimumab, a monoclonal antibody, in patients with idiopathic membranous nephropathy (IMN). IMN is an auto-immune disease; the immune system is overactive and attacks normal cells, causing kidney damage. Protein leaks through the kidney into the urine. Belimumab is used to treat another auto-immune disease, Lupus. It calms down the immune system which may help patients with idiopathic membranous nephropathy. All study subjects will take belimumab or placebo for approximately 2 years (100 weeks), whilst continuing to take their background supportive treatment. Belimumab and the placebo will be given by a one-hour infusion into the veins on 0, 2 and 4 weeks and then every 4 weeks until Week 100. Some study subjects may need to be treated every 2 weeks until improvement in the level of protein leak into the urine. The first couple of visits may take up to 4 hours. The study starts with a Screening Period for up to 35 days to see if the patients are eligible followed by a Treatment Period (100 weeks) and a Follow-Up Period (12 weekly visits), which together may run for up to 2 years and 6 months. The tests/procedures include: ?½ Physical examination, ?½ Medical, medication, drug and alcohol history, ?½ Heart monitoring, ?½ Blood test to measure the amount of belimumab in the blood ?½ Vital signs: weight, height, blood pressure, temperature, pulse ?½ Blood test to check general health, antibodies and other proteins which are markers of IMN ?½ Hepatitis B and C and HIV antibodies ?½ Pregnancy tests for women who can become pregnant ?½ Urine samples to test the amount of protein and belimumab ?½ 6 minute walk test ?½ Questionnaires

• REC name

  London - Central Research Ethics Committee

• REC reference

  12/LO/1697

• Date of REC Opinion

  29 Oct 2012

• REC opinion

  Favourable Opinion