A Study of the Correlation Between Pharmacokinetic and Pharmacodynamic Parameters of CellCept (Mycophenolate Mofetil).

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the correlation between the pharmacokinetic and pharmacodynamic parameters of CellCept in patients undergoing primary kidney transplantation, in order to assess the impact on clinical outcome and the risks of acute rejection. All patients will receive oral CellCept, 1g twice daily, and pharmacokinetic and pharmacodynamic parameters will be measured at weeks 2, 4, 12 and 24. The anticipated time on study treatment is 24 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Antibodies; Cyclosporine; Cyclosporins; Immunoglobulins; Mycophenolate mofetil; Mycophenolic Acid

Criteria

Inclusion Criteria:

• Adult patients, 18 to 65 years of age

• Patients undergoing primary kidney transplantation

Exclusion Criteria:

• Recipients of multiple organ transplants

• Prior therapy with CellCept

• Presence or history of malignancies, except for successfully treated basal or squamous cell carcinoma of the skin

• Active peptic ulcer or active serious digestive system disease that may affect the absorption of CellCept