Development Clinical Studies - investigation into the efficacy of Mirococept in renal transplantation

This study is designed to improve the immediate function of a kidney transplant and also to improve its longterm outcome. A novel molecule has been designed that binds to the cell membranes of the kidney and reduces the inflammatory response after transplantation. This should result in a shorter hospital stay for the patient and a reduced need for dialysis after transplantation. There is also good evidence that improving the initial function of a kidney can improve longterm fuction, thus improving the outcome for the patient. This would also increase the number of kidneys available for transplanation to those on the waiting list.

We are seeking to define a therapeutic approach to the prevention of damage to the kidney during the period immediately after transplantation. This damage is linked to activation of the complement system which occurs through recognition of the grafted organ as ?non-self? as shown in a MRC funded programme of work. We have approached this problem firstly by engineering a recombinant form of a human complement regulatory molecule known to be present in the normal kidney and secondly by modifying this molecule so that it can be delivered to the graft by perfusion before transplantation and retained within the kidney during the period that damage is thought to occur. Preclinical and exploratory clinical studies have indicated that this approach is safe and has the potential to reduce the incidence of delayed graft function in renal transplantation. We are now seeking to conduct a larger-scale multi-centre Phase II study to investigate the clinical utility of the approach. This will at the same time validate therapeutic targets identified by animal work.