TURING
Research type
Research Study
Full title
A randomised, two-arm (1:1 ratio), double blind, placebo controlled phase III trial to assess the efficacy, safety, cost and cost-effectiveness of rituximab in treating de novo or relapsing NS in patients with MCD/FSGS (TURING)
IRAS ID
258589
Contact name
Lisa Willcocks
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust
Eudract number
2018-004611-50
Duration of Study in the UK
5 years, 6 months, 31 days
Research summary
Minimal Change Disease (MCD) and Focal Segmental Glomerulosclerosis (FSGS) are rare diseases that cause nephrosis. Patients suffer with debilitating oedema, and are at increased risk of infection and venous thromboembolism. Standard of care consists of high dose glucocorticoids, with associated morbidity including weight gain, diabetes, infection and osteoporosis. Patients require frequent hospital visits, hence these diseases carry a high socioeconomic burden. This is particularly high in FSGS, where patients with uncontrolled disease progress to end stage kidney disease (ESKD), at an annual cost of £26,300 for hospital haemodialysis.
Better treatments are needed for MCD/FSGS.
Rituximab is a monoclonal B cell depleting antibody, which is licensed for other autoimmune diseases, including ANCA vasculitis which is also a cause of ESKD. Rituximab has been shown to be safe and effective in delaying relapse in children with relapsing MCD/FSGS, but due to a lack of RCT data, is not funded by NHS England for adults.REC name
London - City & East Research Ethics Committee
REC reference
19/LO/0738
Date of REC Opinion
14 Jun 2019
REC opinion
Further Information Favourable Opinion