Predictive biomarkers of immune response to desensitisation
Research type
Research Study
Full title
Development of a predictive biomarker profile to stratify the response of potential kidney recipients to antibody reduction and immune modulation
IRAS ID
292042
Contact name
Felicity May
Contact email
Sponsor organisation
Velindre University NHS Trust
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
A proportion of patients on the transplant waiting list have high levels of antibodies and are known as ‘highly sensitised’ patients. These antibodies bind to proteins in human tissue called human leukocyte antigen (HLA) and can cause organ rejection and reduce the patient’s chances of being safely transplanted. Treatments have been developed to reduce HLA antibody levels (desensitisation) and allow this disadvantaged group to be safely transplanted. However, desensitisation is known to not be effective for all patients, incurring unnecessary risk and expense for those patients that fail to respond. This project will measure levels of cell signalling molecules (cytokines) in the serum of patients who have received desensitisation treatment to better understand how the treatment effects the patients’ immune systems and inform development of a test to predict patient response. The project will obtain serum samples collected from patients recruited to the ‘ITOPS’ clinical trial (Improving Transplant Options for Patients who are Sensitised, WBSRD0075) for scientific sub-study, and serum samples collected from patients worked up for antibody incompatible transplantation at UHW, stored in Welsh Transplantation and Immunogenetics Laboratory (WTAIL) for clinical investigation. Samples from time intervals pre and post treatment, will be analysed using an assay (Luminex Multiplex) to quantify a bespoke panel of cytokines of interest, as determined by literature review. Significant findings from the Luminex analysis will be validated using enzyme-linked immunosorbent assay (ELISA). This project is being performed in collaboration with the ITOPS Chief Investigator, as part of the Principal Investigator’s Higher Specialist Scientist Training (HSST), supported by the University of Manchester.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
21/EM/0045
Date of REC Opinion
9 Mar 2021
REC opinion
Further Information Favourable Opinion