Erythropoietin and Delayed Graft Function in Renal Allografts from Extended Criteria Donors. - EPO and DGF
- Conditions
- Transplantation of renal allografts from extended criteria donors
- Registration Number
- EUCTR2006-005373-22-GB
- Lead Sponsor
- Central Manchester and Manchester Children's University Hospitals NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
1.Men and women aged = or > 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 (a) or (b) as described below:
a)
Donor conditionDonor age categories
50-59 years>or=60 years
CVA+HTN+SCr>1.5eligibleeligible
CVA+HTN eligibleeligible
CVA+SCr>1.5eligibleeligible
HTN+SCr>1.5eligibleeligible
CVA noeligible
HTN no eligible
SCr>1.5 noeligible
None noeligible
b)Additional criteria
i)anticipated CIT = or > 24hrs
ii)donor with cardiac death
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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 = or > 15g/dl
6. Subjects with a diastolic blood pressure > 100 mm/Hg pre-transplantation.
7. Subjects previously intolerant of NeoRecormon.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method