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
  Purpose

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 Intervention Phase
Kidney Transplantation
Drug: mycophenolate mofetil [CellCept]
Drug: Cyclosporine or tacrolimus
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Viral kinetics [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 155
Study Start Date: December 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: mycophenolate mofetil [CellCept]
Concentration-controlled
Drug: Cyclosporine or tacrolimus
Reduced
Experimental: 2 Drug: mycophenolate mofetil [CellCept]
Concentration-controlled
Drug: Cyclosporine or tacrolimus
Standard, as prescribed
Experimental: 3 Drug: mycophenolate mofetil [CellCept]
1g po bid
Drug: Cyclosporine or tacrolimus
Standard, as prescribed

  Eligibility

Ages Eligible for Study:   13 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients participating in study ML17225.

Exclusion Criteria:

  • N/A.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337493

  Hide Study Locations
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
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00337493     History of Changes
Other Study ID Numbers: ML19199
Study First Received: June 15, 2006
Last Updated: September 14, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Mycophenolic Acid
Mycophenolate mofetil
Tacrolimus
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 24, 2014