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 measure
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 (if study stopped)
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
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
National government
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
Basic results (scientific)
Publication list