Trial Information

Summary: 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 300.

Study Phase: IV

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Open Label
• Control: Active
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: 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:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 13 Years Max: 75 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 06/16/2006

Date Last Updated: 08/18/2008

Link To Trial Results

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Trial listings updated: August 20, 2008 at 2:15:38 PM