Condition category
Surgery
Date applied
28/02/2014
Date assigned
09/04/2014
Last edited
30/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Kidney transplantation is a successful treatment for end-stage renal disease. The standard methods for storing and transporting kidneys for transplantation are to either store them in cold storage solution or to perfuse them with a cold perfusion solution on ice. It has been shown that machine perfusion preservation improves short term graft function, especially in kidneys donated by expanded criteria donors (ECD). Experimental models have shown that it is sufficient to perform machine perfusion immediately prior to implantation and reperfusion of the organ. This would also show a benefit to logistics, as kidneys would only need to be perfused at the transplantation center of the recipient. The aim of this study is to assess whether machine perfusion only immediately prior to implantation and after transport in cold storage solution will reduce damage, decrease ischemia-reperfusion injury and improve graft survival and function in ECD kidneys.

Who can participate?
Kidneys donated after brain death from donors fulfilling the United Network for Organ Sharing (UNOS) ECD criteria.

What does the study involve?
Two groups will be compared: a control group (static cold storage) and an interventional group (hypothermic oxygenated machine perfusion after static cold storage).

What are the possible benefits and risks of participating?
Short-term hypothermic oxygenated machine perfusion may be beneficial to static cold storage in ECD kidneys. In this study, two standard preservation methods are being compared.

Where is the study run from?
The trial will be carried out in academic hospitals with an active adult kidney transplant programme in Germany, Belgium, the Netherlands, United Kingdom and their donor hospitals. The lead center will be the University Hospital Essen, Germany.

When is the study starting and how long is it expected to run for?
It is anticipated that recruitment will start in May 2014. Participants will be enrolled and followed-up in the study for a period of one year.

Who is funding the study?
European Union

Who is the main contact?
Professor Andreas Paul

Trial website

http://www.cope-eu.org/work-packages/wp3

Contact information

Type

Scientific

Primary contact

Prof Andreas Paul

ORCID ID

Contact details

Department of General
Visceral and Transplant Surgery
University Hospital Essen
Hufelandstr. 55
Essen
45147
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A prospective, randomized, parallel group, single blinded, controlled, multi-center, non-paired superiority trial to compare the effect of short-term 'in house' oxygenated hypothermic machine perfusion preservation after static cold storage to static cold storage alone in transplantation of expanded criteria donor (ECD) kidneys donated after brain death

Acronym

COPE-POMP (Consortium for Organ Preservation in Europe - Pre-implantation Oxygenated hypothermic Machine Perfusion)

Study hypothesis

Short-term reconditioning using hypothermic oxygenated machine perfusion preservation following static cold storage and prior to reimplantation is superior to static cold storage alone in ECD kidneys.

Ethics approval

Ethics Board of the Faculty of Medicine, University of Duisburg-Essen, 25/09/2014, ref: 14-5783-BO

Study design

Prospective randomized parallel group patient-blinded controlled multi-center non-paired superiority trial

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 for ECD kidneys

Intervention

ECD kidneys will be randomized to be preserved using either static cold storage alone or static cold storage followed by hypothermic oxygenated machine perfusion.

Group 1 - control group: the kidney wil be retrieved and stored in cold storage solution until back-table preparation and kidney transplantation are performed.

Group 2 - experimental group: the kidney will be placed in cold storage solution until arrival at the recipient's transplant center. Following back-table preparation the kidney will be placed on the Kidney Assist device to be perfused with cold oxygenated Belzer's Machine preservation solution until immediately before implantation.

The previous sponsor for this trial (up to 24/04/2014) was:
University Hospital Essen (Germany)
Hufelandstr. 55
Essen
45147
Germany
http://uk-essen.de/

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Graft survival after 1 year

Secondary outcome measures

1. Patient and graft survival at day 7, and at 3, 6 and 12 months after transplantation
2. Estimated glomerular filtration rate (eGFR) defined by the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation at days 7 and 14 and 3, 6 and 12 months after transplantation
3. Delayed graft function (DGF), defined as the need for dialysis within the first 7 days after transplantation and preceding the return of kidney function
4. Slow graft function (SGF) based on functional DGF (fDGF), 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 7 days after transplantation
5. Primary non-function (PNF), defined as the continued need for dialysis at 3 months after transplantation
6. Biopsy proven acute rejection incidence
7. Quality of life measures (EQ-5D-5L) at time of consent, 3 and 12 months
8. Health economic analysis: length of hospital stay, intensive care unit stay, requirement of dialysis
9. Incidence of hyperkalemia at 3, 6 and 12 months
10. Incidence of calcineurin inhibitor toxicity

Overall trial start date

01/05/2014

Overall trial end date

31/10/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Donors:
1. Kidneys from brain dead donors fulfilling the United Network for Organ Sharing ECD criteria

Recipient:
1. At least 18 years old.
2. Listed for renal transplantation due to end stage renal disease within one of the participating centers
3. The transplantation is the participant's first or re-transplantation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

262

Participant exclusion criteria

Donor:
1. Kidney used for a multi-organ transplantation
2. Donor aged 85 or older
3. Donation after cardiac death
4. Kidney used for double-kidney transplantation within the same recipient

Recipient:
1. Simultaneous participation in another perfusion trial
2. Scheduled to undergo multi-organ transplantation
3. Planned dual-kidney transplantation
4. Both kidneys being transplanted within the same recipient
5. Is unable or unwilling to provide informed consent

Recruitment start date

01/05/2014

Recruitment end date

31/10/2016

Locations

Countries of recruitment

Belgium, Germany, Netherlands, United Kingdom

Trial participating centre

Department of General, Visceral and Transplant Surgery
University Hospital Essen
Essen
45147
Germany

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

c/o Ms Heather House
Joint Research Office
Block 60
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LE
United Kingdom

Sponsor type

University/education

Website

http://www.nds.ox.ac.uk/

Funders

Funder type

Government

Funder name

European Union - Seventh Framework Programme (FP7) (grant number 305934 - Work Package 3)

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

Additional files

Editorial Notes

30/03/2016: Ethics approval information added.