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

Completed

Conditions: Renal transplantation
Surgery
Other complications of surgical and medical care, not elsewhere classified

Registration Number: ISRCTN85447324

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

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

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®

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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<br>2. Kidney function using standard clinical parameters will be monitored post-operatively, and at 3, 6, 9 and 12 months