Clinical Trial Protocol Registry

Trial information

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

Status:
Completed
Protocol number:
ML19199
Sponsor:
Hoffmann-La Roche
Company division:
Pharmaceutical
Official Scientific Title:
A study to investigate the impact of pharmacogenetics on CellCept use, in patients participating in a study in renal transplantation
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. Target sample size is 155.
Study phase:
IV
Study type:
Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/efficacy study
Conditions:
  • Kidney Transplantation
Intervention type:
Drug
Intervention name:
mycophenolate mofetil [CellCept]
Primary outcome:
  1. 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
Key secondary outcomes:
  1. Viral kinetics Time frame: Throughout study
Inclusion criteria:
  • patients participating in study ML17225.
Exclusion criteria:
  • N/A.
Gender:
Males or Females
Age limits:
Min: 13 years Max: 75 years
Accepts healthy volunteers:
No
Anticipated start date:
December, 2005
Trial registration date:
19.05.2006
Date last updated:
22.01.2010
This trial was conducted at the following locations:
U.S.A.
  • BIRMINGHAM, AL
  • LOS ANGELES, CA
  • DENVER, CO
  • GAINESVILLE, FL
  • ORLANDO, FL
  • AUGUSTA, GA
  • CHICAGO, IL
  • INDIANAPOLIS, IN
  • LEXINGTON, KY
  • SHREVEPORT, LA
  • BOSTON, MA
  • CHAPEL HILL, NC
  • FARGO, ND
  • HACKENSACK, NJ
  • LIVINGSTON, NJ
  • BUFFALO, NY
  • PORTLAND, OR
  • PHILADELPHIA, PA
  • MADISON, WI
UNITED STATES
  • LITTLE ROCK, AR

Link to trial result

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