EMPIRIKAL
Research type
Research Study
Full title
EMPIRIKAL – A Double Blind Randomized Controlled Investigation into the efficacy of Mirococept (APT070) for preventing ischaemia-reperfusion injury in the kidney allograft (EMPIRIKAL)
IRAS ID
101921
Contact name
Martin Drage
Contact email
Sponsor organisation
King's College London
Eudract number
2011-000958-30
ISRCTN Number
ISRCTN49958194
Duration of Study in the UK
2 years, 2 months, 1 days
Research summary
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. The reintroduction of the blood supply to the organ can cause tissue damage after a period of ischaemia or lack of oxygen.
One of the factors that can contribute to the damage of the kidney can potentially be blocked by a drug called Mirococept.
The aim of this study is to give this drug to the kidney (ex-vivo), after the kidney has been removed from the donor and before it is transplanted into the participant.
The trial is designed to test the superiority of Mirococept in the prevention of Ischaemia Reperfusion Injury (IRI) in deceased donor renal allografts, as compared to standard cold perfusion fluid (Soltran).
All patients on the renal transplant waiting list of participating centres will receive an information sheet informing them about the study.
Participants will be randomised to treatment or placebo, and randomization will be carried out in blocks, and stratified by centre and type of donor (Donation after circulatory death [DCD]/Donation after Brain Death [DBD])All participants will receive the standard immunosuppression protocol consisting of induction with basiliximab (anti-CD25) and maintenance immunosuppression with mycophenolate mofetil, tacrolimus and prednisolone, to prevent rejection of the kidney transplant. In addition two-thirds of the participants will receive a donor kidney that has already been treated with the study medication. To follow up the effect of this treatment on the kidney we will need to take some blood samples and urine samples during their routine outpatient clinic visits during the first year.
This is a multi-centre double-blind randomized study so that neither the participant nor the doctors and nurses assessing them will know who has received the mirococept treated kidney. As mirococept is administered as a single treatment to the kidney ex-vivo and is cytotopic, very little is expected to enter the systemic circulation.
Consenting participants will be randomly assigned to either the placebo or mirococept perfused organ.
The trial is being support by the Medical Research Council (MRC) within the UK Clinical Research Network (UKCRN) and by the British Transplantation Society (BTS).
The main outcome measure is to reduce Delayed Graft Function (DGF) as estimated by the number of patients requiring dialysis in the first week, but we will also monitor side effects and safety.REC name
London - South East Research Ethics Committee
REC reference
12/LO/1334
Date of REC Opinion
22 Feb 2013
REC opinion
Further Information Favourable Opinion