This study will determine which, if any, allelic variants of mycophenolic acid (MPA) metabolizing enzymes, drug transporters and drug targets are associated with the observed variation in pharmacokinetic and pharmacodynamic outcomes observed with CellCept usage. Patients participating in study ML17225 will be eligible for this pharmacogenetic investigation, and will have one additional blood sample taken during the study. The anticipated time on study treatment in study ML17225 is 1-2 years, and the target sample size is 500+ individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
155
Concentration-controlled
1g po bid
Reduced
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Little Rock, Arkansas, United States
Correlation of allelic variants of MPA metabolizing genes, membrane transporter genes and target genes with AUC, transplant rejection, GER and drug side effects.
Time frame: Throughout study
Viral kinetics
Time frame: Throughout study
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Standard, as prescribed
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Denver, Colorado, United States
Unnamed facility
Gainesville, Florida, United States
Unnamed facility
Orlando, Florida, United States
Unnamed facility
Augusta, Georgia, United States
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
Indianapolis, Indiana, United States
Unnamed facility
Lexington, Kentucky, United States
...and 10 more locations