Role of B cell markers and rituximab levels in membranous nephropathy
Research type
Research Study
Full title
The role of B cell biomarkers and rituximab levels in developing a personalised immunosuppression strategy for patients with idiopathic membranous nephropathy – an exploratory pilot study
IRAS ID
300301
Contact name
Arif Khwaja
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Idiopathic membranous nephropathy (IMN) is an autoimmune disease that causes nephrotic syndrome in adults. This is where increased protein loss in the urine leads to oedema (swelling) and progressive kidney failure. Around 50% of patients require treatment with drugs that suppress the immune system. Such therapy (immunosuppression) usually consists of either Rituximab (a monoclonal antibody) or cyclophosphamide (which non-specifically targets immune cells in the bone marrow). Both therapies reduce immune cells such as B cells and plasmablasts which are responsible for producing the autoantibodies that cause IMN.
However, the optimal duration of treatment is unknown. In autoimmune diseases such as Systemic Lupus Erythematosus, measuring plasmablasts can help predict the likelihood of relapse and reduce the duration of treatment required. For patients treated with Rituximab, measuring Rituximab levels in the blood may predict response to treatment and need for retreatment.
This pilot study is important as it evaluates whether measuring plasmablasts in IMN can be used to predict who is likely to go into remission and who will need further immunosuppression. It will also evaluate whether measuring Ritxuimab levels in the blood can be used to predict the need for re-dosing with Rituximab at 6 months. The benefit for patients is that in the future this may allow us to individualise the duration of therapy for patients avoiding unnecessary and toxic treatment for some patients.
All patients with IMN who require treatment with either Rituximab or cyclophosphamide will be eligible for the study. The study will take place in the renal outpatients at the Sheffield Kidney Institute. It will involve patients providing extra samples of blood and urine in addition to those taken for their standard care. The study will last for two years. It will be funded from the research funds within the renal directorate at Sheffield Teaching Hospital NHS Foundation Trust.REC name
West Midlands - Black Country Research Ethics Committee
REC reference
21/WM/0284
Date of REC Opinion
10 Dec 2021
REC opinion
Favourable Opinion