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
1 other identifier
interventional
155
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2005
Typical duration for phase_4
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 15, 2006
CompletedFirst Posted
Study publicly available on registry
June 16, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedSeptember 17, 2012
September 1, 2012
2.1 years
June 15, 2006
September 14, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Viral kinetics
Throughout study
Study Arms (3)
1
EXPERIMENTAL2
EXPERIMENTAL3
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- patients participating in study ML17225.
You may not qualify if:
- N/A.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Unknown Facility
Birmingham, Alabama, 35294, United States
Unknown Facility
Little Rock, Arkansas, 72205-7199, United States
Unknown Facility
Los Angeles, California, 90057, United States
Unknown Facility
Denver, Colorado, 80262, United States
Unknown Facility
Gainesville, Florida, 32610-0224, United States
Unknown Facility
Orlando, Florida, 32804, United States
Unknown Facility
Augusta, Georgia, 30912, United States
Unknown Facility
Chicago, Illinois, 60637, United States
Unknown Facility
Indianapolis, Indiana, 46202-5167, United States
Unknown Facility
Lexington, Kentucky, 40536-0293, United States
Unknown Facility
Shreveport, Louisiana, 71130, United States
Unknown Facility
Boston, Massachusetts, 02111, United States
Unknown Facility
Hackensack, New Jersey, 07601, United States
Unknown Facility
Livingston, New Jersey, 07039, United States
Unknown Facility
Buffalo, New York, 14203, United States
Unknown Facility
Chapel Hill, North Carolina, 27599, United States
Unknown Facility
Fargo, North Dakota, 58122, United States
Unknown Facility
Portland, Oregon, 97210, United States
Unknown Facility
Philadelphia, Pennsylvania, 19104, United States
Unknown Facility
Madison, Wisconsin, 53792, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2006
First Posted
June 16, 2006
Study Start
December 1, 2005
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
September 17, 2012
Record last verified: 2012-09