Status:
COMPLETED
MPA PK Monitoring Strategy With MMF/FK Based Immunosuppression
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Transplantation, Renal
Immunosuppression
Eligibility:
All Genders
18-80 years
Phase:
EARLY_PHASE1
Brief 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 measur...
Detailed Description
We would use repeated Areas-Under-the-Curve (AUC-a statistical means of summarizing information from a series of measurements on one individual) during the first month post transplant to establish a t...
Eligibility Criteria
Inclusion
- Male and female, age 18-80
- On Cellcept (MMF) and Prograf (tacrolimus) based immunosuppression
- Recipient of cadaveric or living donated kidney transplants
Exclusion
- Documented non-compliance prior transplant
- Serum albumin \<2.5 mg/dl
- Primary non-function
- Not on Prograf
- Pregnant females
- Active serious digestive system disorder
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00187941
Start Date
August 1 2005
End Date
November 1 2006
Last Update
June 20 2012
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610