Contact information
Type
Scientific
Primary contact
Dr Michael Picton
ORCID ID
Contact details
Department of Nephrology
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
+44 (0)161 276 4290
Michael.picton@cmmc.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
10322
Study information
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
Acronym
EPOTRIAL
Study hypothesis
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
Central Manchester Research Ethics Committee approved on the 25th July 2007 (ref: 07/Q1407/94)
Study design
Single centre randomised double blind parallel-group placebo 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
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 names
Erythropoietin
Primary outcome measure
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
Secondary outcome measures
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
2. Kidney function using standard clinical parameters will be monitored post-operatively, and at 3, 6, 9 and 12 months
Overall trial start date
01/09/2007
Overall trial end date
30/06/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant 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®
Recruitment start date
01/09/2007
Recruitment end date
30/06/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Nephrology
Manchester
M13 9WL
United Kingdom
Sponsor information
Organisation
Central Manchester and Manchester Children's University Hospital (CMMCUH) NHS Trust (UK)
Sponsor details
c/o Lynne Webster
Research and Development Department
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
+44 (0)161 276 4125
lynne.webster@cmft.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Roche (UK) (ref: Neo 034)
Alternative name(s)
F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche & Co, F. Hoffmann-La Roche AG
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
Switzerland
Funder name
Central Manchester and Manchester Children's University Hospital (CMMCUH) NHS Trust (UK)
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
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25643790