Kidney transplantation MedDRA version: 6.1 Level: PT Classification code 10023439
Conditions
Interventions
Trade Name: CellCept
Pharmaceutical Form: Tablet
INN or Proposed INN: Mycophenolic acid
CAS Number: 115007-34-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Sponsors
ROCHE
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: 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;Primary end point(s): provide a preliminary evaluation of the correlation between the pharmacokinetic and pharmacodynamic | — |
Countries
Italy
Outcome results
None listed