Short term outcomes of DCD renal transplantation
Research type
Research Study
Full title
Short term outcomes of Donation after Circulatory Death (DCD) renal transplantation in the United Kingdom
IRAS ID
213985
Contact name
Chris Watson
Contact email
Sponsor organisation
GSK
Duration of Study in the UK
1 years, 9 months, 0 days
Research summary
This retrospective observational study will assess short term outcomes following kidney transplantation, and provide historical data standard of care data to align with GSK Study 204824 (A Phase II, Pilot, Multicentre, Single Arm Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GSK1070806 plus Standard of Care for the Prevention of Delayed Graft Function in Adult Subjects After Renal Transplantation) that is evaluating a potential new drug for kidney transplantation.
Our primary endpoints include the frequency of delayed graft function after transplant, number of dialysis events in first 30 days after transplant, frequency of rejection episodes during 1-year of follow-up, 1-year graft survival, all-cause mortality, longitudinal serum creatinine/eGFR (kidney function markers) during first year post transplant.
Our primary study population consists of approximately 500-1000 subjects from the UK Transplant Registry, specifically from selected transplant centers participating in the GSK Study 204824. Study participants are recipients of a Donation after Circulatory Death (DCD) kidney, are first or second-time, single kidney-only transplant recipients that underwent transplantation between 2010 and mid-2015, and are aged 18 years or older. A sub-population of this larger dataset, will be subsequently identified that reflects the GSK Study 204824 population.
Serum creatinine data and dialysis episode information is only available at limited time points in the UK Transplant Registry and hence this data will be supplemented by abstraction of data from medical charts at the participating transplant centers.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
16/EE/0506
Date of REC Opinion
12 Jan 2017
REC opinion
Further Information Favourable Opinion