Pharmacogenetic Study of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00337493

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 IV

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Tacrolimus Cyclosporin Cyclosporine Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Study to Investigate the Impact of Pharmacogenetics on CellCept Use, in Patients Participating in a Study in Renal Transplantation

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 Completion Date:	January 2008

Arms	Assigned Interventions
1: Experimental	Drug: mycophenolate mofetil [CellCept] Concentration-controlled Drug: Cyclosporine or tacrolimus Reduced
2: Experimental	Drug: mycophenolate mofetil [CellCept] Concentration-controlled Drug: Cyclosporine or tacrolimus Standard, as prescribed
3: Experimental	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

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

Show 20 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML19199
Study First Received:	June 15, 2006
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00337493
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Cyclosporine
Clotrimazole
Miconazole
Tioconazole

Mycophenolic Acid
Mycophenolate mofetil
Tacrolimus
Cyclosporins

Additional relevant MeSH terms:

Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antibiotics, Antineoplastic

Immunosuppressive Agents
Pharmacologic Actions
Antifungal Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 16, 2009