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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00337493

Enrollment

155

Registered

2006-06-16

Start date

2005-12-31

Completion date

2008-01-31

Last updated

2012-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

Brief 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.

Interventions

DRUGmycophenolate mofetil [CellCept]

Concentration-controlled

DRUGCyclosporine or tacrolimus

Reduced

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

13 Years to 75 Years

Healthy volunteers

Inclusion criteria

* patients participating in study ML17225.

Exclusion criteria

* N/A.

Design outcomes

Primary

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.	Throughout study

Secondary

Measure	Time frame
Viral kinetics	Throughout study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026