Renal protection against ischaemia-reperfusion in transplantation

ISRCTN	ISRCTN30083294
DOI	https://doi.org/10.1186/ISRCTN30083294
Protocol serial number	EME 08/52/02; 2 version 7
Sponsor	University College London (UCL) (UK)
Funder	Medical Research Council (MRC)/National Institutes of Health Research (NIHR) (UK) - Efficacy and Mechanism Evaluation (EME) Programme (ref: EME 08/52/02)

Submission date: 08/06/2009
Registration date: 09/07/2009
Last edited: 29/05/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Raymond MacAllister
Scientific

BHF Laboratories
5 University Street
London
WC1E 6JJ
United Kingdom

Email	r.macallister@ucl.ac.uk

Study information

Primary study design	Interventional
Study design	Double-blind factorial design randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Renal protection against ischaemia-reperfusion in transplantation: a double-blind randomised controlled trial with a factorial design
Study acronym	REPAIR
Study objectives	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(s)	University College London Hospitals Local Research Ethics Committee (UCLH LREC) Committee alpha, 08/06/2009, ref: 09/H0715/48
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Glomerular filtration rate (GFR) 12 months after transplantation.
Key secondary outcome measure(s)	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
Completion date	01/04/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	400
Key inclusion criteria	1. Patients undergoing living donor transplantation 2. Patients aged 18 years and above, either sex
Key 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
Date of first enrolment	01/10/2009
Date of final enrolment	01/04/2013

Locations

Countries of recruitment

United Kingdom
England
Netherlands

Study participating centre

BHF Laboratories

London
WC1E 6JJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes