Renal protection against ischaemia-reperfusion in transplantation
| ISRCTN | ISRCTN30083294 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30083294 |
| Secondary identifying numbers | EME 08/52/02; 2 version 7 |
- 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
Not provided at time of registration
Contact information
Prof Raymond MacAllister
Scientific
Scientific
BHF Laboratories
5 University Street
London
WC1E 6JJ
United Kingdom
| r.macallister@ucl.ac.uk |
Study information
| Study design | Double-blind factorial design randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 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(s) | University College London Hospitals Local Research Ethics Committee (UCLH LREC) Committee alpha, 08/06/2009, ref: 09/H0715/48 |
| 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 |
| Primary outcome measure | 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 study start date | 01/10/2009 |
| Overall study end date | 01/04/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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 |
| Recruitment start date | 01/10/2009 |
| Recruitment end date | 01/04/2013 |
Locations
Countries of recruitment
- England
- Netherlands
- United Kingdom
Study participating centre
BHF Laboratories
London
WC1E 6JJ
United Kingdom
WC1E 6JJ
United Kingdom
Sponsor information
University College London (UCL) (UK)
University/education
University/education
Joint Biomedical Research Unit
1st Floor, Maple House
149 Tottenham Court Road
London
W1T 7NF
England
United Kingdom
| r.macallister@ucl.ac.uk | |
| Website | http://www.ucl.ac.uk/joint-rd-unit/about-us |
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Government
Medical Research Council (MRC)/National Institutes of Health Research (NIHR) (UK) - Efficacy and Mechanism Evaluation (EME) Programme (ref: EME 08/52/02)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
