Erythopoietin and delayed graft function in renal allografts from extended criteria donors

ISRCTN	ISRCTN85447324
DOI	https://doi.org/10.1186/ISRCTN85447324
Secondary identifying numbers	10322

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

Department of Nephrology
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom

Phone	+44 (0)161 276 4290
Email	Michael.picton@cmmc.nhs.uk

Study information

Study design	Single centre randomised double blind parallel-group placebo 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	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	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 study start date	01/09/2007
Completion date	30/06/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	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

England
United Kingdom

Study participating centre

Department of Nephrology

Manchester
M13 9WL
United Kingdom

Sponsor information

Central Manchester and Manchester Children's University Hospital (CMMCUH) NHS Trust (UK)
Hospital/treatment centre

c/o Lynne Webster
Research and Development Department
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
England
United Kingdom

Phone	+44 (0)161 276 4125
Email	lynne.webster@cmft.nhs.uk
Website	http://www.cmft.nhs.uk/
"ROR"	https://ror.org/00he80998

Funders

Funder type

Government

Roche (UK) (ref: Neo 034)
Government organisation / For-profit companies (industry)

Alternative name(s): F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche & Co, F. Hoffmann-La Roche AG, Roche Holding AG, Roche Holding Ltd, Roche Holding, Roche Holding A.G., Roche Holding, Limited, F. Hoffmann-La Roche & Co.
Location: Switzerland

Central Manchester and Manchester Children's University Hospital (CMMCUH) NHS Trust (UK)

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	03/02/2015		Yes	No