E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
We will investigate the effect of recombinant human erythropoietin (rHuEPO) on ischemia-reperfusion injury in patients with terminal renal failure undergoing cadaveric kidney transplantation. In this clinical setting rHuEPO is expected to have anti-apoptotic tissue protective effects.
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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 |
To study the effect of recombinant human erythropoietin (rHuEPO) on ischemia-reperfusion injury after kidney transplantation, i.e. to investigate the effect of rHuEPO on the course of renal function after successful kidney transplantation (e.g. serum-creatinine/serum cystatin C concentration 42 days after kidney transplantation). |
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E.2.2 | Secondary objectives of the trial |
To assess safety and tolerabilty of high dose rHuEPO in patients with terminal renal failure undergoing cadaveric kidney transplantation. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• written informed consent • male or female gender • age between 18 and 70 years • cadaveric kidney transplantion • cold ischemia time below 24 hours prior to transplantation of the kidney • treatment with standard immunosupressive agents after transplantation • HbA1C below 9% in patients with diabetes mellitus • hemoglobin >8 g/dl und <16 g/dl prior to kidney transplantation
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E.4 | Principal exclusion criteria |
• myelodyplastic syndrome or proliferative disease • cancer within 5 years prior to kidney transplantation • advanced renal anemia prior to kidney transplantation • polyglobulia with persistent hemoglobin >16 g/dl • treatment with other growth factors (e.g. GM-CSF) • bleeding episodes within 3 month prior to kidney transplantation • uncontrolled arterial hypertension • known hypersensitivity against rHuEPO • cardiovascular event within 6 month prior to kidney transplantation • thromembolic event within 6 month prior to kidney transplantation • chronic infection and/or persistent high sensitivity CRP >10 mg/l • chronic haemolytic disorders (e.g. thalassemia) • other organ transplants (e.g. combined pancreas/kidney transplantation) • women of childbearing potential without appropriate contraception • psychiatric disease or epilepsia • participation in another clinical trial within 30 days prior to inclusion
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary study end point is the serum-creatinine/serum cystatin C concentration 42 days after successful cadaveric kidney transplantation. In addition, the duration of renal replacement therapy (if any) will be assessed. |
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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 | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
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 | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | No |
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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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 | |
E.8.9.1 | In the Member State concerned days | |