MPA PK Monitoring Strategy With MMF/FK - Full Text View

Sponsors and Collaborators:	University of Florida Hoffmann-La Roche
Information provided by:	University of Florida
ClinicalTrials.gov Identifier:	NCT00187941

Purpose

Individuals absorb Cellcept at different rates and it is difficult to determine an individuals level of MMF(Cellcept)from a single measurement. We will enroll 20 subjects and draw a trough level of MMF, then levels 30 and 120 min. after they take their morning dose. 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.

Condition	Intervention
Kidney Transplantation	Drug: Therapeutic drug levels

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Mycophenolate Mofetil Mycophenolate mofetil hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title:	Pilot Trial for Implementation of a MPA PK Monitoring Strategy in Patients on MMF/FK Based Immunosuppression.

Further study details as provided by University of Florida:

Primary Outcome Measures:

Proportion of pt's who's measured AUC falls within or outside the MPA target range (30-60 mg/L) at any given follow up interval, as averaged over the whole time period and proportions of patients achieving one or more therapeutic level AUC

Estimated Enrollment:	20
Study Start Date:	August 2005
Study Completion Date:	February 2008
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Detailed Description:

As above

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female, age 18-80
On Cellcept and Prograf
Living or cadaveric transplant

Exclusion Criteria:

Non-compliance
Serum albumin <2.5 mg/dl
Primary non-function
Not on Prograf
Pregnant
Serious active digestive system disorder

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187941

Sponsors and Collaborators

University of Florida

Hoffmann-La Roche

Investigators

Principal Investigator:

Herwig-Ulf Meier-Kriesche, MD

University of Florida

More Information

Study ID Numbers:	CEL470
Study First Received:	September 13, 2005
Last Updated:	June 4, 2008
ClinicalTrials.gov Identifier:	NCT00187941
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Florida:

transplant
renal
Cellcept
therapeutic drug level

Study placed in the following topic categories:

Mycophenolate mofetil

ClinicalTrials.gov processed this record on January 15, 2009