Pharmacogenetic Study of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.
Phase 4
Completed
- Conditions
- Kidney Transplantation
- Interventions
- Registration Number
- NCT00337493
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 155
Inclusion Criteria
- patients participating in study ML17225.
Exclusion Criteria
- N/A.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 mycophenolate mofetil [CellCept] - 1 Cyclosporine or tacrolimus - 2 mycophenolate mofetil [CellCept] - 2 Cyclosporine or tacrolimus - 3 mycophenolate mofetil [CellCept] - 3 Cyclosporine or tacrolimus -
- Primary Outcome Measures
Name Time Method Correlation of allelic variants of MPA metabolizing genes, membrane transporter genes and target genes with AUC, transplant rejection, GER and drug side effects. Throughout study
- Secondary Outcome Measures
Name Time Method Viral kinetics Throughout study