Delayed Graft Function Clinical Trial
Official title:
A Three-Part, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Sequential Adaptive, Phase II Study to Evaluate the Safety, Tolerability and Efficacy of OPN-305, a Humanised Monoclonal Antibody That Blocks Toll-Like Receptor 2, in Renal Transplant Patients at High Risk of Delayed Graft Function
When a patient receives a kidney transplant particularly if the kidney is from an older
donor or one who has had the kidney removed after their heart has stopped, there is a risk
that the newly transplanted kidney may not function immediately. If the delay in function
means that dialysis is needed in the first 7 days after the transplantation then this is
known as delayed graft function or dDGF. Also delayed graft function that does not require
dialysis but is present because the serum creatinine does not fall sufficiently is known as
functional delayed graft function or fDGF. This problem is often due to an excessive
inflammatory reaction to not having had a blood supply between the time of donation and
transplant.
OPN-305 is a monoclonal antibody that blocks Toll-like Receptor 2 which is thought to be
partly responsible for increasing the risk of this inflammation. It is hoped that the
effects of the inflammation will be reduced and therefore prevent dDGF and fDGF from
occurring.
The purpose of the study is to explore how effective OPN-305 is in preventing dDGF and fDGF
as well as improving other measures of kidney function and the overall safety of the
antibody. In the first part of the study, each patient received an Infusion of one of three
possible doses of OPN-305 or a placebo and in the second part the most suitable dose of
OPN-305 and a placebo would be used. The purpose of this second part of the study is to find
out if a dose of OPN-305 which has already been tested in an earlier part of this study can
prevent kidney graft dysfunction. For the purposes of this study, kidney function will be
assessed using the composite of delayed graft function (dDGF) because dialysis is necessary
in the first 7 days and functional delayed graft function that does not require dialysis but
is present because the serum creatinine, a key measure of renal function, does not fall
sufficiently (fDGF) in the first 7 days post-transplant.
Protocol OPN305-103 follows out to 12 months post-transplant the clinical status and graft
function of patients who have completed the 6-month post-transplant period under Part A or
Part B of OPN305-102.
n/a
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