A Pharmacokinetic Study of CellCept (Mycophenolate Mofetil) Versus Mycophenolate Sodium in Kidney Transplant Patients

Roche

Status and phase

Completed

Phase 4

Conditions

Kidney Transplantation

Treatments

Drug: MMF

Drug: EC-MPS

Drug: Prednisone

Study type

Interventional

Funder types

Industry

Identifiers

NCT01033864

2009-012355-15

ML22641

Details and patient eligibility

About

This open-label, 2-arm study will compare the pharmacokinetics of CellCept and mycophenolate sodium in kidney transplanted patients on a calcineurininhibitor-free mycophenolic acid-based therapy. On the study day patients will take their prescribed medication (either CellCept or mycophenolate sodium). Blood samples will be drawn directly before and at intervals up to 12 hours after intake of the study medication. Anticipated time on study treatment is 12 hours and target sample size is 24.

Enrollment

23 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

adult patients, >/=18 years of age
kidney transplantation >/=6 months ago
on mycophenolic acid-based, calcineurininhibitor-free therapy for >/=3 months, >/=1 month on stable dose
co-therapy with 5mg prednisone for >/=1 month

Exclusion criteria

active gastrointestinal ulcus
severe diarrhea od gastrointestinal disease
severe impairment of renal function
current malignancy
Lesch-Nyhan- or Kelley-Seegmiller-Syndrome

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

23 participants in 2 patient groups

MMF, Prednisone

Experimental group

Description:

Participants received mycophenolate mofetil (MMF) orally (PO) at a dose of 1 gram per day (g/day) twice daily (BID), and prednisone, PO, up to 5 milligrams per day (mg/day) for at least 1 month.

Treatment:

Drug: MMF

Drug: Prednisone

EC-MPS

Active Comparator group

Description:

Participants received mycophenolate sodium (EC-MPS), PO, at a dose of 720 mg/day BID, and prednisone PO up to 5 mg/day for at least 1 month.

Treatment:

Drug: EC-MPS

Drug: Prednisone