Condition category
Injury, Occupational Diseases, Poisoning
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English 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 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?
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

Trial website

Contact information



Primary contact

Mr Martin Drage


Contact details

MRC Centre for Transplantation
NIHR Biomedical Research Centre - Transplant Theme
Kings College London
5th Floor Tower Wing
Guy's Hospital
Great Maze Pond Road
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

An Investigation into the Efficacy of Mirococept (APT070) for Preventing Ischaemia-Reperfusion Injury in the Kidney ALlograft (EMPIRIKAL)



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).

Ethics approval

Not provided at time of registration

Study design

Multi-centre double-blind randomized case-control trial cumulative cohort design

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Ischaemia-reperfusion injury associated with renal transplantation


Mirococept (Active IMP) or Soltran (Placebo) perfused through donor kidney via the renal artery, under 1 meter hydrostatic pressure prior to transplantation.

Intervention type



Not Applicable

Drug names

Mirococept, Soltran

Primary outcome measures

To reduce Delayed Graft Function (DGF) as estimated by the number of patients requiring dialysis in the first week.

Secondary outcome measures

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

Overall trial start date


Overall trial end date


Reason abandoned


Participant 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

Participant type


Age group




Target number of participants


Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

MRC Centre for Transplantation
United Kingdom

Sponsor information


King’s College London (UK)

Sponsor details

United Kingdom
+44 (0)20 7188 5732

Sponsor type




Funder type

Research council

Funder name

Medical Research Council (MRC) grant ref: G1001197/1

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes