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 | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare the composite efficacy failure rate (treated BPAR, graft loss, death, loss to follow-up) between de novo transplant patients treated with Certican and reduced Neoral dose and Myfortic with standard Neoral dose at 12 months. |
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E.2.2 | Secondary objectives of the trial |
Efficacy: To compare the incidence of graft loss, death or loss to follow up (composite) between Certican and Myfortic treatment arms at 12 months post-transplantation. Safety: To compare renal function (calculated GFR using the MDRD formula (Coresh et. al. 2003) between Certican treatment arms and the Myfortic treatment arm at 12 months post-transplantation.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
AMENDMENT 2 RELATED CHANGES SHOWN IN CAPITALS:
• Male or female renal recipients 18-70 years of age undergoing primary kidney transplantation, females not pregnant or lactating ADDED:FEMALES MUST HAVE A NEGATIVE PREGNANCY TEST PRIOR TO RANDOMISATION • Recipients of primary cadaveric, living unrelated or non HLA identical living related donor - THIS SENTENCE IS DELETED • Patients who have given written informed consent to participate in the study
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E.4 | Principal exclusion criteria |
• Cold ischemia time >40 hours, non-heartbeating donor , donor age >65 • Patients with platelet count <100,000/mm at the evaluation before randomization. • Patients with an absolute neutrophil count of < 1,500/mm³ at baseline before surgery or white blood cell count of < 4,500/mm³ • Patients who are recipients of multiple solid organ transplants, or who previously received an organ transplant • Patients who have severe hypercholesterolemia (>350 mg/dL; >9 mmol/L) or hypertriglyceridemia (>500 mg/dL; >8.5 mmol/L). Patients with controlled hyperlipidemia are acceptable • Patients who have an abnormal liver profile such as ALT, AST, Alk Phos or total bilirubin >3 times the ULN • Patients who are treated with drugs that are strong inducers or inhibitors of cytochrome P450, patients treated with terfenadine, astemizole, cisapride or lovastatin - LOVASTATIN IS DELETED • Patients who received an investigational drug or who have been treated with a non-protocol immunosuppressive drug or treatment within 30 days or 5 half-lives prior to randomization • Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin • Patients with current Panel Reactive Antibodies >20%, recipients of ABO incompatible transplants or T cell crossmatch positive transplant. • Patients who are HIV-positive or Hepatitis C (PCR+ only) or B surface antigen positive. BECOMES: PATIENTS WHO HAVE TESTED POSITIVE FOR HIV, HEPATITIS C OR HEPATITIS B SURFACE ANTIGEN • Recipients of organs from donors who test positive for Hepatitis B surface antigen or Hepatitis C (PCR+ only) are excluded • Patients with a history of severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus • Patients who have any surgical or medical condition, which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism and excretion of study medication, and/or the presence of severe diarrhea or active peptic ulcer • Patients with abnormal physical or laboratory findings of clinical significance within 2 weeks of randomization which would interfere with the objectives of the study • Patients with any history of coagulopathy or medical condition requiring long-term anticoagulation after transplantation. (Low dose aspirin treatment is allowed) ADDED: RECIPIENTS OF KIDNEYS FROM HLA-IDENTICAL LIVING RELATED DONORS RECIPIENTS OF DUAL KIDNEY TRANSPLANTS PATIENTS WITH MOST RECENT ANTI-HLA CLASS I PANEL REACTIVE ANTIBODIES >20% by a CDC-(COMPLEMENT DEPENDENT CYTOTOXICITY) -BASED ASSAY OR >50% BY A FLOW CYTOMETRY OR ELISA (ENZYME LINKED IMMUNOSORBENT ASSAY)- BASED ASSAY |
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E.5 End points |
E.5.1 | Primary end point(s) |
To compare the composite efficacy failure rate (treated BPAR, graft loss, death, loss to follow-up) between de novo transplant patients treated with Certican and reduced Neoral dose and Myfortic with standard Neoral dose at 12 months. |
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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 | No |
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) | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
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) | Yes |
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
| Information not present in EudraCT |
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 | Information not present in EudraCT |
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 | 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 | 1 |
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 | 1 |