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An investigation into the treatment of the donor kidney to see if this improves the recovery of the kidney after transplantation
ISRCTN ISRCTN49958194
DOI 10.1186/ISRCTN49958194
ClinicalTrials.gov identifier
EudraCT number
Public title An investigation into the treatment of the donor kidney to see if this improves the recovery of the kidney after transplantation
Scientific title An Investigation into the Efficacy of Mirococept (APT070) for Preventing Ischaemia-Reperfusion Injury in the Kidney ALlograft (EMPIRIKAL)
Acronym EMPIRIKAL
Serial number at source MD-001
Study hypothesis This is a multi-centre double-blind randomized case-control trial, designed to test the superiority of Mirococept in the prevention of Ischaemia-Reperfusion Injury (IRI) in cadaveric renal allografts, as compared to standard cold perfusion fluid (Soltran).
Lay summary 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?
All patients on the renal transplant waiting list will receive an information sheet about the study.

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 100mg 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?
This study is expected to start recruiting in October 2012 and recruitment closes in May 2014.

Who is funding the study:
The study is being funded by the Medical Research Council (MRC) and King’s College London is the leading site.

Who is the main contact?
Mrs Marie Thornhill, Study Project Manager
marie.thornhill@kcl.ac.uk
Ethics approval Not provided at time of registration
Study design Multi-centre double-blind randomized case-control trial cumulative cohort design (CCD)
Countries of recruitment United Kingdom
Disease/condition/study domain Ischaemia-Reperfusion Injury associated with Renal Transplantation
Participants - inclusion criteria 1. Patient must be 16 years of age or older
2. Patient must be willing to participate in the study & provide written informed consent
3. Patient must have the ability to comply with the study requirements
4. Donor must be older than 10 years of age
Participants - exclusion criteria 1. Patient is recipient of a living-donor kidney
2. Patient is not yet on dialysis
3. Patient is a recipient of a Donation after Cardiac Death (DCD) kidney Maastricht category 1 or 2
4. Patient has evidence of current or previous infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV)
5. Patient is recipient of an en bloc double renal transplant
6. The donor kidney has more than 2 renal arteries, unless the artery is small enough to be ligated and not perfused.
7. Any ABO or HLA incompatible transplant
8. Patients receiving donor organs with a cold ischaemic time >30 hours
9. Any recipient of a multi-organ transplant or a previous recipient of a non-renal solid organ transplant
10. Females who are pregnant or lactating
11. Patients not willing to use contraception for at least one month post transplant
12. Patients with a history of malignancy within the last 5 years, except adequately treated squamous or basal cell carcinomas of the skin or cervical intraepithelial neoplasia
13. Patients involved in other experimental drug trials
14. Patients who might be expected to have an allergic response to the molecule
Anticipated start date 18/10/2012
Anticipated end date 30/05/2015
Status of trial Ongoing
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 560
Interventions Mirococept (Active IMP) or Soltran (Placebo) perfused through donor kidney via the renal artery, under 1 meter hydrostatic pressure prior to transplantation.
Primary outcome measure(s) To reduce Delayed Graft Function (DGF) as estimated by the number of patients requiring dialysis in the first week.
Secondary outcome measure(s) 1. To include reducing the delay of recovery in those grafts with immediate function independent of dialysis
2. To determine if treatment influences renal function/histology at 12 months (a surrogate of long term graft outcome) and acute rejection episodes during this time
Sources of funding Medical Research Council (MRC) grant ref: G1001197/1
Trial website
Publications
Contact name Mr  Martin  Drage
  Address MRC Centre for Transplantation
NIHR Biomedical Research Centre - Transplant Theme
Kings College London
5th Floor Tower Wing
Guy's Hospital
Great Maze Pond Road
  City/town London
  Zip/Postcode SE1 9RT
  Country United Kingdom
Sponsor King’s College London (UK)
  Address Strand
  City/town London
  Zip/Postcode WC2 2LS
  Country United Kingdom
  Tel +44 (0)20 7188 5732
  Fax +44 (0)20 7188 8330
  Email jackie.pullen@kcl.ac.uk
Date applied 15/06/2012
Last edited 03/08/2012
Date ISRCTN assigned 03/08/2012
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