E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
de novo kidney transplantation |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to determine whether tacrolimus dose reduction can preserve renal function in de novo renal recipients receiving tacrolimus in addition to Certican™, IL-2 receptor antagonist and corticosteroids. This objective will be assessed by comparing renal function evaluated by calculated glomerular filteration rate (GFR) (MDRD formula) at 12 months post-transplant between two groups of patients receiving two different exposure levels of tacrolimus. |
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E.2.2 | Secondary objectives of the trial |
The main secondary objective is to assess efficacy of the two regimens. This will be evaluated by the comparison between the two groups of the incidence of biopsy-proven acute rejection (BPAR) from Month 4 until Month 12 after transplantation. The other secondary objectives are to assess the efficacy and safety of the two regimens. This will be evaluated at 12 months by the comparison between the two groups of the two regimens
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
The investigator must ensure that each patient meet all the following inclusion criteria at baseline immediately prior to randomization: • Male or female of 18-65 years old • Patient who has received a primary kidney transplant from a cadaveric, living unrelated or non-HLA identical living related donor • Recipient of a kidney with a cold ischemic time (CIT) < 30 hours • Recipient of a kidney from a donor 10-65 years old • Patient able to receive the first dose of tacrolimus within 24 hours from graft reperfusion • Female capable of becoming pregnant must have a negative pregnancy test and is required to practice a medically approved method of birth control for the duration of the study and for a period of three months following discontinuation of investigational drug • Patient willing and capable of giving written informed consent for study participation and able to participate in the study for 12 months
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E.4 | Principal exclusion criteria |
The patient meeting any of the following criteria at baseline just before randomization will be excluded from study participation: • Patient who has previously received an organ transplant • Recipient of multiple organ transplants • Recipient of a kidney transplant from a non heart-beating donor • Recipient of donor specific transfusions • Recipient of A-B-O incompatible transplant or T-cell cross-match positive transplant • Patient with current Panel Reactive Antibodies (PRA) level ≥ 50% • Recipient of a kidney from a donor who tests positive for Hepatitis B surface antigen or Hepatitis C antibodies • Patient who is human immunodeficiency virus (HIV) positive • Patient who has a positive Hepatitis C serology or who is Hepatitis B surface antigen positive with evidence of liver injury as indicated by AST/ALT levels ≥ 2.5 times UNL. Viral serology results obtained within 6 months prior to the administration of the first dose of Certican™ are acceptable • Patient with severe hypercholesterolemia (≥ 350 mg/dL, 9.1 mmoL/dL) or hypertriglyceridemia (≥ 500 mg/dL, 5.6 mmoL/L) • Patient with white blood cell (WBC) count < 3,000/mm3 or with platelet count ≥ 75,000/mm3 • Patient with any severe allergy requiring acute (within 4 weeks of baseline) or chronic treatment, or with hypersensitivity to drugs similar to Certican™ (e.g., macrolides)™ • Patient who has been treated with an immunosuppressive drug or an investigational drug within 4 weeks prior to the administration of the first dose of Certican™ • Patient with uncontrolled infection • Patient with any surgical or medical condition, other than the current transplant, which in the opinion of the investigator, precludes enrollment in this trial • Patient with a known malignancy or a history of malignancy within last 5 years other than successfully treated localized basal or squamous cell carcinoma of the skin • Abnormal physical or laboratory findings of clinical significance within 2 weeks prior to the administration of the first dose of Certican™ which at investigator’s discretion would interfere with the objectives of the study • Breast feeding women • Patient with symptoms of significant somatic or mental illness or with unresolved history of drug or alcohol abuse • Patient unable to cooperate or communicate with the investigator
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E.5 End points |
E.5.1 | Primary end point(s) |
The renal function will be assessed at 12 months post transplant, by serum creatinine, calculated creatinine clearance (Cockcroft Gault formula), calculated GFR (MDRD formula and Nankivell formula). Quantitative proteinuria will also be calculated. |
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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 | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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 | No |
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 | No |
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.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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 | |
E.8.9.2 | In all countries concerned by the trial years | 2 |