E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 primary objective of the study is the assessment of the overall graft rejection rate (acute, chronic and subclinical) between a treatment with ATG-Fresenius administered in addition to standard treatment consisting of CellCept® or Myfortic®/TAC and without corticosteroids and a treatment consisting of CellCept® or Myfortic®/TAC and corticosteroids during the first year after renal transplantation. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective of the study are: - The assessment of the safety in use of ATG-Fresenius in this patient population, i.e., adverse events, in particular infections, malignancies, arterial hypertension, hyperlipidaemia, post-transplant diabetes mellitus, cataracts, bone fractures or osteoporosis, cardiovascular complications, development of anti-drug antibodies and specific and unspecific rabbit immunoglobulin. - The assessment of further efficacy data in terms of time of onset, severity and steroid resistance of rejections, subclinical rejections, incidence and duration of initial delayed graft function, renal function, proteinuria, patient/graft survival, and weight and body mass index. In addition, re-hospitalization episodes and duration will be recorded.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients will be enrolled in this study only if they meet all of the following criteria: • Signed and dated informed consent form. • End-stage renal disease. • Candidates for a first transplantation. Re-transplant patients are eligible if a graft loss after transplantation was NOT due to immunological reasons. • Availability of a heart-beating cadaveric donor up to 70 years of age with a cold ischemia time < 36 hours. • Male or female patients between 18 to 75 years of age (inclusive). • Patients able to comply with all study related requirements. • Patients able to receive oral medication. • Women of childbearing age with a safe contraceptive method throughout the study.
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E.4 | Principal exclusion criteria |
Patients will not be enrolled in this study if they meet any of the following criteria: • Women who are pregnant or breast feeding. • Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection (patients and respective donors). • Severe actual viral, bacterial or fungal infection not adequately controlled. • Patients with anamnestically known hypersensitivity to rabbit immunoglobulin antibodies or positive rabbit immunoglobulin skin test or known allergies to any component of the immunosuppressive drugs per protocol. • Patients at high immunological risk defined as current PRA ≥ 25% or historical PRA ≥ 50%. • Patients receiving pre-transplant immunosuppressive treatment, including corticosteroids. • Patients with current or history of malignancies (exception basal cell carcinoma or squamous cell carcinoma in remission). • Patients with previous transplantation except 1st graft loss due to surgical complications. • Patients receiving combined transplantation. • Patients with major organ dysfunctions. • Serious psychiatric or psychological disorders. • Pre-transplant thrombocytopenia: < 50,000 thrombocytes/µl. • Pre-transplant leukopenia: < 2,000 leukocytes/µl. • Unable or unwilling to comply fully with the protocol. • Participation in another study of an investigational medicinal product concurrently or within the last 30 days.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the incidence of biopsy-proven acute allograft rejection after 12 months, including all types of rejections like: • acute rejection • chronic rejection • subclinical rejection
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
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.8.2 | 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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
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 | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |