MPA PK Monitoring Strategy With MMF/FK Based Immunosuppression

Completed · Early Phase 1

Conditions studied: Transplantation, Renal, Immunosuppression

In brief

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.

Key facts

Study ID

NCT00187941

Run by

University of Florida

People needed

22

Starts

2005-08-01

Expected to finish

2006-11-01

Last updated by the study team

2012-06-20

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female, age 18-80
• On Cellcept (MMF) and Prograf (tacrolimus) based immunosuppression
• Recipient of cadaveric or living donated kidney transplants

You may not qualify if…

• Documented non-compliance prior transplant
• Serum albumin <2.5 mg/dl
• Primary non-function
• Not on Prograf
• Pregnant females
• Active serious digestive system disorder

Where it is running

• University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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