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 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

Trial website

Contact information

Type

Scientific

Primary contact

Mr Martin Drage

ORCID ID

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
London
SE1 9RT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MD-001

Study information

Scientific title

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

Acronym

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 (CCD)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

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

Condition

Ischaemia-Reperfusion Injury associated with Renal Transplantation

Intervention

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

Intervention type

Drug

Phase

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

18/10/2012

Overall trial end date

30/05/2015

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

Target number of participants

560

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

18/10/2012

Recruitment end date

30/05/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Centre for Transplantation
London
SE1 9RT
United Kingdom

Sponsor information

Organisation

King’s College London (UK)

Sponsor details

Strand
London
WC2 2LS
United Kingdom
+44 (0)20 7188 5732
jackie.pullen@kcl.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Editorial Notes