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

Roche

Status and phase: Completed; Phase 4

Conditions: Kidney Transplantation

Treatments: Drug: mycophenolate mofetil [CellCept]; Drug: Cyclosporine or tacrolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00337493

ML19199

Details and patient eligibility

About

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.

Enrollment: 155 patients

Sex: All

Ages: 13 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients participating in study ML17225.

Exclusion criteria

• N/A.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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155 participants in 3 patient groups

1

Experimental group

Treatment:

Drug: mycophenolate mofetil [CellCept]

Drug: mycophenolate mofetil [CellCept]

Drug: Cyclosporine or tacrolimus

Drug: Cyclosporine or tacrolimus

2

Experimental group

Treatment:

Drug: mycophenolate mofetil [CellCept]

Drug: mycophenolate mofetil [CellCept]

Drug: Cyclosporine or tacrolimus

Drug: Cyclosporine or tacrolimus

3

Experimental group

Treatment:

Drug: mycophenolate mofetil [CellCept]

Drug: mycophenolate mofetil [CellCept]

Drug: Cyclosporine or tacrolimus

Drug: Cyclosporine or tacrolimus