Study of safety and effects of GSK1070806 in Delayed Graft Function
Research type
Research Study
Full title
A Phase 2 Pilot, Multicenter, 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
IRAS ID
196099
Contact name
Mr Ewen Harrison
Contact email
Sponsor organisation
GlaxoSmithKiline
Eudract number
2015-002812-33
Duration of Study in the UK
1 years, 4 months, 11 days
Research summary
Sometimes, kidney transplants do not work immediately after they are implanted, meaning the recipient needs to return to dialysis for a while (usually a few days) until the kidney begins to function. This condition is known as delayed graft function (DGF). If DGF occurs, doctors believe that the transplant may not work so well in the long term, or even fail more quickly.
GlaxoSmithKline (GSK) is developing a new medicine GSK1070806 which is a monoclonal antibody (a type of protein that is engineered to resemble a human protein) .
All patients participating in this study will receive a single dose of GSK1070806 by IV Infusion immediately before or during their transplant operation. They will then be followed for a period of one year during which efficacy and safety assessments will be performed. This will include physical examinations, vital signs, clinical laboratory tests, 12 lead electrocardiograms and monitoring of adverse events.
Up to 40 people from 4 centers in the UK will take part in this study. According to the NHS Blood and Transplant data base these 4 centers all have a similar rate of delayed graft function over the previous several years, use a similar standard of care and also have access to the particular patients required by the study (Donation after Circulatory Death DCD kidney transplant patients). Additionally the leads from these centres are all experts in the field of kidney transplant and associated research, with each unit containing an active research group/resource to help deliver this study.
REC name
Scotland A: Adults with Incapacity only
REC reference
16/SS/0015
Date of REC Opinion
18 Feb 2016
REC opinion
Further Information Favourable Opinion