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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00337493
Recruitment Status : Completed
First Posted : June 16, 2006
Last Update Posted : September 17, 2012
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: mycophenolate mofetil [CellCept] Drug: Cyclosporine or tacrolimus Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Investigate the Impact of Pharmacogenetics on CellCept Use, in Patients Participating in a Study in Renal Transplantation
Study Start Date : December 2005
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Arm Intervention/treatment
Experimental: 1 Drug: mycophenolate mofetil [CellCept]

Drug: Cyclosporine or tacrolimus

Experimental: 2 Drug: mycophenolate mofetil [CellCept]

Drug: Cyclosporine or tacrolimus
Standard, as prescribed

Experimental: 3 Drug: mycophenolate mofetil [CellCept]
1g po bid

Drug: Cyclosporine or tacrolimus
Standard, as prescribed

Primary Outcome Measures :
  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 ]

Secondary Outcome Measures :
  1. Viral kinetics [ Time Frame: Throughout study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients participating in study ML17225.

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00337493

  Hide Study Locations
United States, Alabama
Birmingham, Alabama, United States, 35294
United States, Arkansas
Little Rock, Arkansas, United States, 72205-7199
United States, California
Los Angeles, California, United States, 90057
United States, Colorado
Denver, Colorado, United States, 80262
United States, Florida
Gainesville, Florida, United States, 32610-0224
Orlando, Florida, United States, 32804
United States, Georgia
Augusta, Georgia, United States, 30912
United States, Illinois
Chicago, Illinois, United States, 60637
United States, Indiana
Indianapolis, Indiana, United States, 46202-5167
United States, Kentucky
Lexington, Kentucky, United States, 40536-0293
United States, Louisiana
Shreveport, Louisiana, United States, 71130
United States, Massachusetts
Boston, Massachusetts, United States, 02111
United States, New Jersey
Hackensack, New Jersey, United States, 07601
Livingston, New Jersey, United States, 07039
United States, New York
Buffalo, New York, United States, 14203
United States, North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, North Dakota
Fargo, North Dakota, United States, 58122
United States, Oregon
Portland, Oregon, United States, 97210
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT00337493     History of Changes
Other Study ID Numbers: ML19199
First Posted: June 16, 2006    Key Record Dates
Last Update Posted: September 17, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents