Extract

Background and aims Before a kidney can be transplanted into a recipient it has to be removed from the donor and transported to the hospital of the recipient. During this period the kidney does not have a blood supply and is stored in a cold solution to minimise damage caused by lack of blood supply. One of the factors that can contribute to the damage of the kidney can potentially be blocked by a drug called Mirococept. In this study the drug is given to the kidney, after the kidney has been removed from the donor and before it is transplanted into the recipient. The aim of the study is to find out whether damage to the kidney can be prevented and to see if the new treatment improves the function of the kidney and whether this might extend the life of the kidney. Who can participate? Patients aged 16 years or older who are on the kidney transplant waiting list and are receiving a kidney from a donor aged 10 or older. What does the study involve: The study involves a single treatment to the donor kidney prior to transplantation. Post transplant recipients will follow their routine transplant assessment and clinic visits. Additional blood and urine samples will be collected for the study to assess whether the study drug has worked. Study assessments will be followed up for 1 year. What are the possible benefits and risks of participating? The purpose of the study is to see if we can reduce the chance of patients needing dialysis after they have had the transplant. By reducing the damage to a kidney during the time it does not have a blood supply we also aim to find out if we can reduce the chance of long-term damage to the kidney. In general, a kidney transplant lasts on average 10 years and one of the aims is to see if the treatment will lengthen the lifespan of new kidney transplants. As mirococept (study drug) is administered as a single treatment to the donor kidney prior to transplant, there is very little risk for it to enter the systemic circulation of the recipient. In the initial part of this study (in health volunteers) showed, doses up to 100 mg given systemically were well tolerated. Where is the study run from? The study is taking place at NHS hospitals across the UK. When study starting and how long is it expected to run for? October 2012 to May 2018 Who is funding the study: Medical Research Council (UK) Who is the main contact? 1. Dr Martin Drage (scientific) 2. Miss Laura Nicols (public)

Inclusion criteria

• Ischaemia-Reperfusion Injury associated with Renal Transplantation

Links

• isrctn
• ictrp