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)

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.

Principal Investigator

Dr Philip D Mason

Contact us

Email: renalandtransplanttrials@ouh.nhs.uk

IRAS number

258589