Condition category
Injury, Occupational Diseases, Poisoning
Date applied
24/10/2013
Date assigned
11/12/2013
Last edited
11/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Kidney transplantation is a successful treatment for end-stage renal disease. The standard method of storing and transporting a kidney for transplantation is to perfuse with a cold perfusion solution and store the kidney in an ice box. It has already been shown that machine perfusion preservation improves short term graft function. The aim of this study is to assess whether adding oxygen during the hypothermic machine perfusion (HMP) will reduce damages, decrease ischaemia-reperfusion injury and improve graft function.

Who can participate?
Kidneys donated after circulatory death from donors who are 50 years old or older transplanted into 2 different recipients.

What does the study involve?
Two groups will be compared: a control group (hypothermic machine perfusion with no addition of oxygen) and an intervention group (hypothermic machine perfusion with added oxygen).

What are the possible benefits and risks of participating?
It has been shown that machine perfusion preservation improves short term graft function. The addition of oxygen during hypothermic machine perfusion may be beneficial and may improve graft function.

Where is the study run from?
The trial will be carried out in academic hospitals with an active adult kidney transplant programme in Belgium, the Netherlands and the Southern region of the United Kingdom and their donor hospitals. The lead centre will be University Hospitals Leuven, Belgium.

When is the study starting and how long is it expected to run for?
February 2015 to June 2018

Who is the main contact?
1. Dr Jacques Pirenne (scientific)
jacques.pirenne@uzleuven.be
2. Professor Ina Jochmans (scientific)
ina.jochmans@uzleuven.be

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jacques Pirenne

ORCID ID

Contact details

Abdominal Transplant Surgery
University Hospitals Leuven
Herestraat 49
Leuven
3000
Belgium
+32 16 34 87 27
jacques.pirenne@uzleuven.be

Type

Scientific

Additional contact

Prof Ina Jochmans

ORCID ID

Contact details

Abdominal Transplant Surgery
University Hospitals Leuven
Herestraat 49
Leuven
3000
Belgium
+32 16 34 87 27
ina.jochmans@uzleuven.be

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

s55952

Study information

Scientific title

A multicentre, double blind, randomised, parallel-group, paired trial to compare the effect of hypothermic machine perfusion preservation with and without the addition of oxygen in transplantation of Maastricht category III kidneys donated after circulatory death from donors aged 50 years or older

Acronym

COPE-COMPARE

Study hypothesis

Oxygenated hypothermic machine perfusion (HMP) is superior for storage of kidneys of donation after cardiovascular death (DCD) category III donors than non-oxygenated (HMP).

Ethics approval

Commissie Medische Ethiek UZ Leuven, September 2014, ref: ML10722

Study design

Randomised controlled surgeon, patient and treating physician blinded multicentre superiority trial with two parallel groups

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Machine perfusion preservation techniques of kidney grafts

Intervention

Hypothermic machine perfusion (HMP) with and without the addition of oxygen.

Group 1 – control group: the kidney will be placed on the Kidney Assist HMP device and perfused with Belzers Machine Preservation Solution at a pulsatile pressure of 25 mmHg starting immediately after retrieval until back-table preparation immediately before kidney transplantation.

Group 2 – intervention group: the kidney will be placed on the Kidney Assist HMP device and perfused with oxygenated Belzers Machine Preservation Solution at a pulsatile pressure of 25 mmHg starting immediately after retrieval until back-table preparation immediately before kidney transplantation.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Kidney graft function as measured by a 24-hour creatinine clearance at 1 year after transplantation

Secondary outcome measures

1. Delayed graft function (DGF) - DGF defined as the need for dialysis (excluding one time dialysis for hyperkalaemia or fluid overload) within the first 7 days after kidney transplantation and preceding the return of kidney function. Functional DGF defined as the absence of a decrease in the serum creatinine level of at least 10% per day for at least 3 consecutive days in the first week after transplantation, not including patients in whom acute rejection or calcineurin inhibitor toxicity is proven on biopsy.
2. Primary non function (PNF) defined as the permanent lack of function of the graft from time of transplantation until months post-transplant. This endpoint is determined post-hoc at 3 months post-transplant.
3. Biopsy proven acute rejection within first year post transplant.
4. Length of recipient hospital stay
5. Estimated glomerular filtration rate according to the 4-variable Modification of Diet in Renal Disease (MDRD) equation at 3 months, 6 months and 1 year after transplantation
6. 1 year graft (censored and uncensored for recipient death) survival
7. 1 year patient survival

Overall trial start date

22/02/2015

Overall trial end date

30/06/2018

Reason abandoned

Eligibility

Participant inclusion criteria

Donors:
1. All potential consecutive Maastricht category III DCD donors aged 50 years or older from the collaborating donor regions

Recipient:
1. At least 18 years old
2. Listed for renal transplantation due to end stage renal disease
3. Willingness to comply with the protocol procedures for the duration of the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

162 donors

Participant exclusion criteria

Donor:
1. An aortic patch too small for a reliable connection
2. Too many renal arteries preventing a safe connection

Recipient:
1. Multi-organ transplantation
2. Planned dual kidney transplantation
3. The recipient is unable or unwilling to give informed consent

Recruitment start date

22/02/2015

Recruitment end date

30/06/2017

Locations

Countries of recruitment

Belgium, Netherlands, United Kingdom

Trial participating centre

University Hospitals Leuven
Leuven
3000
Belgium

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Wellington Square
Oxford
OX1 2JD
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Seventh Framework Programme (Grant number 305934 – Work Package 4)

Alternative name(s)

EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Belgium

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

11/02/2016: The study contact Professor Ina Jochmans has been added. On 10/12/2015 the following changes were made to the trial record: 1. The acronym was changed from COMPARDT to COPE-COMPARE. 2. The overall trial start date was changed from 01/01/2014 to 22/02/2015. 3. The overall trial end date was changed from 30/06/2017 to 30/06/2018. 4. The sponsor was changed from University Hospitals Leuven to University of Oxford.