Status:
COMPLETED
Pilot Trial for Implementation of a MPA PK Monitoring Strategy
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Transplant, Kidney
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This study is a prospective interventional trial of de novo renal transplant recipients, aiming to validate a strategy which combines the use of early post transplant MPA AUC sampling, and subsequent ...
Detailed Description
Mycophenolate mofetil or MMF (CellCept® by Roche) is the mofetil ester of mycophenolic acid (MPA), the active immunosuppressant. MMF significantly decreases the episodes of acute rejection in kidney ...
Eligibility Criteria
Inclusion
- primary or secondary cadaveric or living donor kidney recipients
- On Cellcept
Exclusion
- Multi organ recipients
- Documented non-compliance
- Not on a calcineurin inhibitor
- GFR \<25 ml/min by Cockcroft Gault equation
- Serum albumin \<2.5 mg/dl
- Pregnant
- Active serious digestive disorder
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00187915
Start Date
July 1 2003
End Date
December 1 2004
Last Update
October 20 2011
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610