Transplantation of renal allografts from extended criteria donors
Conditions
Interventions
Trade Name: NeoRecormon
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration o
Sponsors
Central Manchester and Manchester Children's University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 condition Donor age categories 50-59 years >or=60 years CVA+HTN+SCr>1.5 eligible eligible CVA+HTN eligible eligible CVA+SCr>1.5 eligible eligible HTN+SCr>1.5 eligible eligible CVA no eligible HTN no eligible SCr>1.5 no eligible None no eligible 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
Exclusion criteria
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 = or > 15g/dl 6. Subjects with a diastolic blood pressure > 100 mm/Hg pre-transplantation. 7. Subjects previously intolerant of NeoRecormon.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal objective of this study is to investigate whether giving erythropoietin (EPO) to patients at the time of kidney transplantation reduces the incidence and/or severity of delayed graft function, when compared to patients who receive a placebo.;Primary end point(s): The primary end point of the trial is the comparison between plasma levels and gene expression of biomarkers between the two arms of the trial at the specified time points.; Secondary Objective: 1. To monitor and compare kidney function in both patient groups post-operatively and at 3, 6, 9 and 12 months 2. To record number and severity of acute rejection episodes. 3. To measure biomarkers involved in ischaemia/reperfusion injury and compare the findings in the EPO group with the placebo group 4. The longer term outcome (at 1 year and 2 years) of the patients in both groups will be followed to compare the incidence of chronic allograft nephropathy. | — |
Countries
United Kingdom
Outcome results
None listed