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

NCT ID: NCT00337493

Last Updated: 2012-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2008-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

mycophenolate mofetil [CellCept]

Intervention Type DRUG

Concentration-controlled

Cyclosporine or tacrolimus

Intervention Type DRUG

Reduced

2

Group Type EXPERIMENTAL

mycophenolate mofetil [CellCept]

Intervention Type DRUG

Concentration-controlled

Cyclosporine or tacrolimus

Intervention Type DRUG

Standard, as prescribed

3

Group Type EXPERIMENTAL

mycophenolate mofetil [CellCept]

Intervention Type DRUG

1g po bid

Cyclosporine or tacrolimus

Intervention Type DRUG

Standard, as prescribed

Interventions

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mycophenolate mofetil [CellCept]

Concentration-controlled

Intervention Type DRUG

mycophenolate mofetil [CellCept]

1g po bid

Intervention Type DRUG

Cyclosporine or tacrolimus

Reduced

Intervention Type DRUG

Cyclosporine or tacrolimus

Standard, as prescribed

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients participating in study ML17225.

Exclusion Criteria

* N/A.
Minimum Eligible Age

13 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Birmingham, Alabama, United States

Site Status

Little Rock, Arkansas, United States

Site Status

Los Angeles, California, United States

Site Status

Denver, Colorado, United States

Site Status

Gainesville, Florida, United States

Site Status

Orlando, Florida, United States

Site Status

Augusta, Georgia, United States

Site Status

Chicago, Illinois, United States

Site Status

Indianapolis, Indiana, United States

Site Status

Lexington, Kentucky, United States

Site Status

Shreveport, Louisiana, United States

Site Status

Boston, Massachusetts, United States

Site Status

Hackensack, New Jersey, United States

Site Status

Livingston, New Jersey, United States

Site Status

Buffalo, New York, United States

Site Status

Chapel Hill, North Carolina, United States

Site Status

Fargo, North Dakota, United States

Site Status

Portland, Oregon, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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ML19199

Identifier Type: -

Identifier Source: org_study_id