E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Classification code | 10023438 |
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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 demonstrate superior renal function at 6 months post-transplant in de novo renal transplant recipients who receive myfortic® and reduced tacrolimus levels (Group A) compared to those who receive myfortic® and reference tacrolimus levels (Group B) as measured by calculated glomerular filtration rate (GFR, Nankivell). Patients will also receive Simulect® (basiliximab) and corticosteroids as concomitant immunosuppressant therapy. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to compare the efficacy, safety, and tolerability of the combination of myfortic®, Simulect®, and corticosteroids with reduced levels of tacrolimus (Group A) versus reference levels of tacrolimus (Group B).
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1.Male or female patients between 18 and 70 years of age 2.Male or female patients who are primary cadaveric, living unrelated or non- Human leukocyte antigen (HLA) identical living related donor renal transplant recipients 3.The renal cold ischemic time (CIT) must be <30 hours 4.The age of the donor must be between 10 and 65 years 5.The patient has given written informed consent to participate in the study
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E.4 | Principal exclusion criteria |
Patients meeting any of the following criteria at baseline will be excluded from study participation. 1.Patients who have previously received an organ transplant 2.Patients who are recipients of a multiple organ transplants 3.Recipients of non heart-beating donor organs 4.ABO incompatibility against the donor 5.Patients with panel reactive antibodies (PRA) of >20% at most recent assessment prior to transplantation 6.Patients who are known to have a positive hepatitis C serology, who are human immunodeficiency virus (HIV) or Hepatitis B surface antigen positive. Laboratory results obtained within 6 months prior to first dose of myfortic® are acceptable. Recipients of organs from donors who test positive for Hepatitis B surface antigen or Hepatitis C are excluded 7.Patients with thrombocytopenia (< 75,000/mm3), with an absolute neutrophil count of <1,500/mm3, and/or leukocytopenia (< 2,500/mm3), or hemoglobin < 6g/dL prior to randomization. 8.Presence of any severe allergy requiring acute (within 4 weeks of baseline) or chronic treatment, or history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures 9.Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer 10.Existence of any surgical or medical condition, other than the current transplant, which in the opinion of the investigator might significantly alter the absorption, distribution, metabolism or excretion of study medication, and/or presence of severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus 11.Patients with clinically significant systemic infection requiring continued therapy 12.Patients with a history of malignancy within the last five years, except for successfully excised squamous or basal cell carcinoma of the skin 13.Abnormal physical or laboratory findings of clinical significance within 2 weeks prior to first dose of myfortic® which at investigators discretion would interfere with the objectives of the study 14.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive Human Chorionic Gonadotropin (hCG) laboratory test 15.Women of child-bearing potential (WOCBP), 16. Patients with symptoms of significant somatic or mental illness. Unresolved history of drug or alcohol abuse 17.Inability to cooperate or communicate with the investigator or unable to complete self administered GI symptoms questionnaires
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint is renal function at 6 months measured by calculated glomerular filtration rate (GFR). |
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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 | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | 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 | 1 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 8 |