Condition category
Surgery
Date applied
07/07/2009
Date assigned
19/08/2009
Last edited
04/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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 NeoRecormonĀ®

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

http://www.cmft.nhs.uk/

Funders

Funder type

Government

Funder name

Roche (UK) (ref: Neo 034)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25643790

Publication citations

Additional files

Editorial Notes