Relationships between pharmacokinetic and pharmacodynamic strategies for assessment of the risks for acute rejection and side effects of mofetil mycophenolate - ND

• Conditions: Kidney transplantation; MedDRA version: 6.1Level: PTClassification code 10023439

• Registration Number: EUCTR2005-006162-33-IT
• Lead Sponsor: ROCHE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 45

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified