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NCT00337493 Clinical Trial

Pharmacogenetic Study of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.

Kidney Transplantation Clinical Trial

Official title:
A Study to Investigate the Impact of Pharmacogenetics on CellCept Use, in Patients Participating in a Study in Renal Transplantation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00337493
Other study ID # ML19199
Secondary ID
Status Completed
Phase Phase 4
First received June 15, 2006
Last updated September 14, 2012
Start date December 2005
Est. completion date January 2008

Study information
Verified date September 2012
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 155
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Both
Age group 13 Years to 75 Years
Eligibility Inclusion Criteria:

- patients participating in study ML17225.

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• mycophenolate mofetil [CellCept]
Concentration-controlled
• mycophenolate mofetil [CellCept]
1g po bid
• Cyclosporine or tacrolimus
Reduced
• Cyclosporine or tacrolimus
Standard, as prescribed

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Viral kinetics Throughout study No
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