Condition category
Injury, Occupational Diseases, Poisoning
Date applied
08/06/2009
Date assigned
09/07/2009
Last edited
29/05/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Raymond MacAllister

ORCID ID

Contact details

BHF Laboratories
5 University Street
London
WC1E 6JJ
United Kingdom
-
r.macallister@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EME 08/52/02; 2 version 7

Study information

Scientific title

Renal protection against ischaemia-reperfusion in transplantation: a double-blind randomised controlled trial with a factorial design

Acronym

REPAIR

Study hypothesis

Remote ischaemic preconditioning reduces ischaemia reperfusion injury to the kidney in living-donor transplantation and improves kidney function.

Link to EME project website: http://www.eme.ac.uk/projectfiles/085202info.pdf
Link to protocol: http://www.eme.ac.uk/projectfiles/085202protocol.pdf

Please note that as of 04/08/10 this record has been updated to reflect changes to the exclusion criteria in the lastest protocol (v.7). Please see the revelant section for more details.

Ethics approval

University College London Hospitals Local Research Ethics Committee (UCLH LREC) Committee alpha, 08/06/2009, ref: 09/H0715/48

Study design

Double-blind factorial design randomised controlled 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

Kidney transplantation

Intervention

The trial will test whether a simple procedure, the application of a blood pressure cuff to the arm of the donor and the recipient before a kidney transplant, can help protect the donor kidney from the harmful effects of the transplant. The blood pressure cuff to be used is similar to the one that is used to measure blood pressure. It will be inflated continuously for a five-minute period, after which it will be deflated for 5 minutes. This cycle of inflation, followed by deflation, will be performed 4 times in total.

The trial follow up is 5 years, performed in the context of routine clinical follow up.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Glomerular filtration rate (GFR) 12 months after transplantation.

Secondary outcome measures

1. Rate of fall in creatinine in the first 72 hours after transplantation
2. Inflammatory response to surgery in the first 5 days after transplantation
3. Protein expression in kidney parenchyma samples using histochemistry
4. Protein activation and expression in renal vasculature using immunoblotting
5. Kidney fibrosis 6 months after transplantation
6. Alloreactivity of T-cells in the first 18 months after transplantation
7. Patient outcomes 2 - 5 years after transplantation using renal registry data

Overall trial start date

01/10/2009

Overall trial end date

01/04/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients undergoing living donor transplantation
2. Patients aged 18 years and above, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. 0,0,0-mismatched renal grafts (no mismatch in HLA-A/B/DR antigens between donor and recipient)
2. Patients on adenosine triphosphate (ATP)-sensitive potassium channel opening or blocking drugs
3. Patients on ciclosporin
4. Patients who have had a previous transplant
5. Patients with a known iodine sensitivity (who cannot undergo iohexol clearance studies)

Added 04/08/2010:
6. Patients with ABO incompatability
7. Any patient requiring HLA antibody removal therapy

Recruitment start date

01/10/2009

Recruitment end date

01/04/2013

Locations

Countries of recruitment

Netherlands, United Kingdom

Trial participating centre

BHF Laboratories
London
WC1E 6JJ
United Kingdom

Sponsor information

Organisation

University College London (UCL) (UK)

Sponsor details

Joint Biomedical Research Unit
1st Floor
Maple House
149 Tottenham Court Road
London
W1T 7NF
United Kingdom
-
r.macallister@ucl.ac.uk

Sponsor type

University/education

Website

http://www.ucl.ac.uk/joint-rd-unit/about-us

Funders

Funder type

Government

Funder name

Medical Research Council (MRC)/National Institutes of Health Research (NIHR) (UK) - Efficacy and Mechanism Evaluation (EME) Programme (ref: EME 08/52/02)

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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26020087

Publication citations

Additional files

Editorial Notes