MPA PK Monitoring Strategy With MMF/FK Based Immunosuppression

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Individuals absorb Cellcept (MMF/Mycophenolate Mofetil) at different rates and it is difficult to determine an individuals level of Mycophenolate Mofetil (MMF, trade name Cellcept)from a single measurement. We will enroll 20 subjects. Plasma samples to be collected pre-MMF dose (trough level) and at 30 and 120 min after the morning dose of MMF.This will be done weekly for the first month and then monthly for the next 6 mths. We hope to use a calculation of the subjects total MMF level during the first month to set a trough target level to use during the next 6 months.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborator: Hoffmann-La Roche
• Treatments: Mycophenolate mofetil; Mycophenolic Acid

Criteria

Inclusion Criteria:

• Male and female, age 18-80

• On Cellcept (MMF) and Prograf (tacrolimus) based immunosuppression

• Recipient of cadaveric or living donated kidney transplants

Exclusion Criteria:

• Documented non-compliance prior transplant

• Serum albumin <2.5 mg/dl

• Primary non-function

• Not on Prograf

• Pregnant females

• Active serious digestive system disorder