E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10023439 |
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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 provide a preliminary evaluation of the correlation between the pharmacokinetic total MPA concentration at time 0 C0 , 40 min. C0.67 and 2 hours C2 ; free MPA concentration at time 0 C0,free , 40 min. C0.67,free and 2 hours C2,free and pharmacodynamic IMPDH II activity levels and IMPDH I and II gene expression parameters of MPA |
|
E.2.2 | Secondary objectives of the trial |
61485; to evaluate the impact of IMPDH II activity levels on clinical outcome in MMF-treated patients 61485; to evaluate the impact of IMPDH I and IMPDH II gene expression on clinical outcome in MMF-treated patients 61485; to evaluate the impact of MPA free concentrations on clinical outcome in MMF-treated patients 61485; to evaluate the impact of MPA C0, MPA C0.67 and MPA C2 on clinical outcome in MMF-treated patients 61485; to evaluate the safety MMF in terms of incidence of infection, adverse events and malignancies 61485; to determine the predictive performance of IMPDH inhibition for risks of acute rejection and side effects |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Patients undergoing primary kidney transplantation. 2. Patients aged 18 to 65 years. 3. Patients capable of understanding the purposes and risks of the study, who have been fully informed and have given written informed consent to participate in the study |
|
E.4 | Principal exclusion criteria |
1. Pregnant women or nursing mothers. 2. Patients who are recipients of multiple organ transplants. 3. Patients unwilling or unable to use adequate contraception during the study. 4. Patients with malignancies or history of malignancy, except a non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully. 5. Patients with active peptic ulcer or with active serious digestive system disease that may affect the absorption of Mycophenolate Mofetil MMF . 6. Patients who have previously received Mycophenolate Mofetil MMF . 7. Patients with any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may invalidate communication with the investigator. 8. Patients who are simultaneously participating in any other investigational drug study or who have participated in a study of an investigational drug within 28 days of entry into this study. 9. Patients with known sensitivity polysorbate 80, to Mycophenolate Mofetil MMF or structurally related compounds. 10. Patients requiring prohibited medications during the study |
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E.5 End points |
E.5.1 | Primary end point(s) |
provide a preliminary evaluation of the correlation between the pharmacokinetic and pharmacodynamic |
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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 | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Information not present in EudraCT |
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 | Information not present in EudraCT |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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 | Yes |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 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 | 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
| |
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 | 6 |
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 | 6 |