E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Transplantation of renal allografts from extended criteria donors |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the intervention phase will be the last sample collection date from the last subject. The end of the observation phase will be the last date of the last recorded clinic visit of the last recruited patient. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |