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

September 14, 2012 updated by: Hoffmann-La Roche

A Study to Investigate the Impact of Pharmacogenetics on CellCept Use, in Patients Participating in a Study in Renal Transplantation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

155

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients participating in study ML17225.

Exclusion Criteria:

  • N/A.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: mycophenolate mofetil [CellCept]
1g po bid
Drug: mycophenolate mofetil [CellCept]
Concentration-controlled
Drug: Cyclosporine or tacrolimus
Reduced
Drug: Cyclosporine or tacrolimus
Standard, as prescribed
Experimental: 2
Drug: mycophenolate mofetil [CellCept]
1g po bid
Drug: mycophenolate mofetil [CellCept]
Concentration-controlled
Drug: Cyclosporine or tacrolimus
Reduced
Drug: Cyclosporine or tacrolimus
Standard, as prescribed
Experimental: 3
Drug: mycophenolate mofetil [CellCept]
1g po bid
Drug: mycophenolate mofetil [CellCept]
Concentration-controlled
Drug: Cyclosporine or tacrolimus
Reduced
Drug: Cyclosporine or tacrolimus
Standard, as prescribed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Throughout study

Secondary Outcome Measures

Outcome Measure
Time Frame
Viral kinetics
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

June 15, 2006

First Submitted That Met QC Criteria

June 15, 2006

First Posted (Estimate)

June 16, 2006

Study Record Updates

Last Update Posted (Estimate)

September 17, 2012

Last Update Submitted That Met QC Criteria

September 14, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML19199

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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