E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Transplantation of a renal graft from a non-heart-beating donor |
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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 |
Main objective of this study is to compare the efficacy and tolerability of polyclonal antibody as induction therapy vs. no antibody induction, with special regard to the incidence of initial delayed graft function.
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E.2.2 | Secondary objectives of the trial |
The main secondary objectives of the trial are: - the duration of initial DGF - Incidence of primary non-functioning grafts. - Acute rejection (biopsy proven): - overall incidence and time until first manifestation - histopathological severity (BANFF) - incidence of subclinical rejection - Renal function as determined by creatinine clearance (MDRD) at 1, 2, and 3 months.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Non-heart-beating-donors (Maastricht III/IV) 2. Female patients of childbearing age agree to maintain effective birth control practice during the study.
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E.4 | Principal exclusion criteria |
1. Pregnant or lactating women at the time of randomization. 2. Patients and donors are ABO incompatible. 3. Women having had >3 pregnancies (including abortions if no consistent data on PRA or anti-donor antibodies are available). 4. Patients with hypersensibility to rabbit proteins, previous treatment with rabbit IgG, or known intolerance to any component of basal immunosuppression. 5. Patients with leukocytes <3,000/mm3 and/or platelets <50,000/mm3 before initiation of transplant. 6. Patients, who are HIV positive. 7. Patients subjected to previous transplants or candidates for multiple transplants (e.g. SKP). 8. Patients, who are unlikely to comply with the visit schedule in the protocol and patients who cannot communicate reliably with the investigator. 9. Patients with pulmonary oedema or with other signs of overhydration. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Incidence of initial DGF (defined as the need for dialysis after transplantation). |
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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 | 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) | Yes |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
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 | No |
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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |