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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00337493
First received: June 15, 2006
Last updated: September 14, 2012
Last verified: September 2012

June 15, 2006
September 14, 2012
December 2005
January 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Correlation of allelic variants of candidate MPA metabolizing genes, membrane transporter genes and target genes with AUC, transplant rejection, GFR and drug side effects.
Complete list of historical versions of study NCT00337493 on ClinicalTrials.gov Archive Site
Viral kinetics [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
None specified
Not Provided
Not Provided
 
Pharmacogenetic Study of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.
A Study to Investigate the Impact of Pharmacogenetics on CellCept Use, in Patients Participating in a Study in Renal Transplantation

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Transplantation
  • Drug: mycophenolate mofetil [CellCept]
    Concentration-controlled
  • Drug: mycophenolate mofetil [CellCept]
    1g po bid
  • Drug: Cyclosporine or tacrolimus
    Reduced
  • Drug: Cyclosporine or tacrolimus
    Standard, as prescribed
  • Experimental: 1
    Interventions:
    • Drug: mycophenolate mofetil [CellCept]
    • Drug: Cyclosporine or tacrolimus
  • Experimental: 2
    Interventions:
    • Drug: mycophenolate mofetil [CellCept]
    • Drug: Cyclosporine or tacrolimus
  • Experimental: 3
    Interventions:
    • Drug: mycophenolate mofetil [CellCept]
    • Drug: Cyclosporine or tacrolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
155
January 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients participating in study ML17225.

Exclusion Criteria:

  • N/A.
Both
13 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00337493
ML19199
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP