Pilot Trial for Implementation of a Medroxyprogesterone(MPA)Pharmacokinetic(PK) Monitoring Strategy in Patients on Mycophenolate Mofetil(MMF)/FK Based Immunosuppression.
Sponsor study identifier
interventional
22
1 country
1
Study Start
August 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2006
Actual (reported)Study Completion
November 2006
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2006
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2005
Date type not reportedThis date has not been verified as actual or estimated.
September 13, 2005
Actual (reported)September 16, 2005
Actual (reported)November 2006
Actual (reported)November 2006
Actual (reported)Proportion of patients whose measured AUC falls within or outside the therapeutic MPA target range (30-60 mg/L/h) at any given follow up interval, as average over the whole time period.
7 months
Proportion of patients achieving one or more therapeutic level AUC.
7 months
Incidence of acute rejection of transplanted kidney
7 months
Incidence of potentially MPA related toxicities
7 months
Number of dose changes needed to achieve MPA AUC target within the first month post-transplant
1 months
Number of dose changes needed to achieve the individualized MPA trough target levels following the first month.
6 months
To obtain 20 to 25 intraindividual correlation estimates (of one type or another) within each patient: trough vs. AUC.
7 months
CellCept + Prograf or Neoral + Steroids
Targeted MPA exposure to 30-60 mg/L/h during the first month post-transplant.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Florida
Gainesville, Florida, 32610, United States
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
Herwig-Ulf Meier-Kriesche, MD
University of Florida
22 participants (actual enrollment reported by the registry).
First Submitted
September 13, 2005
First Posted
September 16, 2005
Study Start
August 2005
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
November 2006
Actual (reported)Study Completion
November 2006
Actual (reported)Last Updated
June 20, 2012
Record last verified: 2012-06
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Source: ClinicalTrials.gov.
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