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

NCT00337493 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2012-09-17

No results posted yet for this study

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.

Conditions

  • Kidney Transplantation

Interventions

DRUG

mycophenolate mofetil [CellCept]

Concentration-controlled

DRUG

mycophenolate mofetil [CellCept]

1g po bid

DRUG

Cyclosporine or tacrolimus

Reduced

DRUG

Cyclosporine or tacrolimus

Standard, as prescribed

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2008-01-31
Completion
2008-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00337493 on ClinicalTrials.gov