Renal protection against ischaemia-reperfusion in transplantation | Not Recruiting
Renal protection against ischaemia-reperfusion in transplantation
REPAIR
Trial Source

Health Conditions
  • Kidney transplantation
Not Recruiting
Recruitment Status
ISRCTN30083294
Primary Trial ID Number
Summary
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.
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
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
University College London Hospitals Local Research Ethics Committee (UCLH LREC) Committee alpha, 08/06/2009, ref: 09/H0715/48
Publications
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26020087
Countries of Recruitment
Netherlands; United Kingdom
Participant Sex
Both
Participant Age Range
Adult
Participant Type
Patient
Trial Sample Size
400
Participant Inclusion Criteria
  • 1. Patients undergoing living donor transplantation
  • 2. Patients aged 18 years and above, either sex
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
Interventions
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.
Design Details
Sorry, this information is not available
Study Design
Double-blind factorial design randomised controlled trial
Results Reporting
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Acronym
REPAIR
Scientific Title
Renal protection against ischaemia-reperfusion in transplantation: a double-blind randomised controlled trial with a factorial design
Secondary Trial Identifying Number
EME 08/52/02; 2 version 7
Website
Sorry, this information is not available
Study Funded By
Medical Research Council (MRC)/National Institutes of Health Research (NIHR) (UK) - Efficacy and Mechanism Evaluation (EME) Programme (ref: EME 08/52/02)
Funder Type
Sorry, this information is not available
Study Sponsored By
University College London (UCL) (UK)
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
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Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment

01 Oct 2009

Recruitment End Date

01 Apr 2013

Trial End Date

01 Apr 2013

Date added to Registry

09 Jul 2009

Last Updated

29 May 2015