drugset / Trial / NCT00187941

MPA PK Monitoring Strategy With MMF/FK Based Immunosuppression

NCT00187941

Phase 0 Completed 22 enrolled University of Florida Hoffmann-La Roche · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2005-08
Primary completion
2006-11
Completion
2006-11

Publications

  • Background Guerra G, Srinivas TR, Schold JD, Eagan AE, Nawrocki, Shaw L, Kaplan B, Womer K, Meier-Kriesche HU. Prospective Blinded Pharmacokinetic Trial to Establish an Individualized MPA Trough Regimen. American Transplant Congress, San Francisco, California

Drugs

EvaluationDrugModalityDoseRoute
Subject Mycophenolate Mofetil Small molecule

Indications

No indication recorded.