Erythopoietin and delayed graft function in renal allografts from extended criteria donors
| ISRCTN | ISRCTN85447324 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85447324 |
| Protocol serial number | 10322 |
| Sponsor | Central Manchester and Manchester Children's University Hospital (CMMCUH) NHS Trust (UK) |
| Funders | Roche (UK) (ref: Neo 034), Central Manchester and Manchester Children's University Hospital (CMMCUH) NHS Trust (UK) |
- Submission date
- 07/07/2009
- Registration date
- 19/08/2009
- Last edited
- 04/02/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Michael Picton
Scientific
Scientific
Department of Nephrology
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
| Phone | +44 (0)161 276 4290 |
|---|---|
| Michael.picton@cmmc.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre randomised double blind parallel-group placebo controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Erythopoietin and delayed graft function in renal allografts from extended criteria donors: a single centre, randomised, double blind, parallel-group, placebo controlled trial |
| Study acronym | EPOTRIAL |
| Study objectives | The principal objective of this study is to investigate whether giving erythropoietin (EPO) to recipients at the time of kidney transplantation will significantly alter the gene expression and protein levels of known biomarkers of ischaemia/reperfusion injury compared to patients receiving placebo. |
| Ethics approval(s) | Central Manchester Research Ethics Committee approved on the 25th July 2007 (ref: 07/Q1407/94) |
| Health condition(s) or problem(s) studied | Renal transplantation |
| Intervention | During implantation of the kidney, after the vascular anastamosis, but prior to clamp release, an intravenous bolus dose of EPO (33,000 iu) or placebo will be administered by the anaesthetist through the central line immediately before the surgeon opens the clamps to allow blood flow into the kidney. An intravenous bolus dose of EPO (33,000 iu) or placebo will be administered to the patient 24 hours and 48 hours following the first 'in surgery' dose. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Erythropoietin |
| Primary outcome measure(s) |
Comparison of plasma and urine levels of biomarkers of acute kidney injury (NGAL, IL-18, HGF, FABP1) between the treatment and placebo groups during the immediate post-operative period |
| Key secondary outcome measure(s) |
1. Comparison of the incidence and severity of delayed graft function and acute rejection between the two arms of the study in the early post-operative period |
| Completion date | 30/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | 1. Men and women aged greater than or equal to 18 years 2. The subject is willing to provide signed written informed consent 3. The subject is the recipient of a deceased donor kidney transplant 4. The donor and/or donor kidney meet at least one of the following extended criteria for organ donation from either 4.1. or 4.2. as described below: 4.1. Donor: Greater than 50 years with: 4.1.1. Cerebrovascular accident (CVA) + hypertension (HTN) + serum creatinine (SCr) greater than 1.5 4.1.2. CVA + HTN 4.1.3. CVA + SCr greater than 1.5 4.1.4. HTN + SCr greater than 1.5 Greater than 60 years with: 4.1.5. CVA 4.1.6. HTN 4.1.7. SCr greater than 1.5 4.2. Additional criteria cold ischaemia time (CIT) greater than or equal to 24 hours |
| Key exclusion criteria | 1. Women who are pregnant or breastfeeding 2. Women with a positive pregnancy test on enrolment 3. Subjects with any active infection that would normally exclude transplantation 4. Subjects who have used any other investigational drug within 30 days prior to transplantation 5. Subjects with a haemoglobin level greater than or equal to 15 g/dl 6. Subjects with a diastolic blood pressure greater than 100 mmHg pre-transplantation 7. Subjects previously intolerant of NeoRecormon® |
| Date of first enrolment | 01/09/2007 |
| Date of final enrolment | 30/06/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Nephrology
Manchester
M13 9WL
United Kingdom
M13 9WL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 03/02/2015 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
