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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Kidney Transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MMF, Prednisone

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.

Group Type EXPERIMENTAL

MMF

Intervention Type DRUG

1 g per day b.i.d. p.o. for at least 1 month

Prednisone

Intervention Type DRUG

5 mg per day p.o.

EC-MPS

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.

Group Type ACTIVE_COMPARATOR

EC-MPS

Intervention Type DRUG

720 mg b.i.d. p.o. for at least 1 month

Prednisone

Intervention Type DRUG

5 mg per day p.o.

Interventions

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MMF

1 g per day b.i.d. p.o. for at least 1 month

Intervention Type DRUG

EC-MPS

720 mg b.i.d. p.o. for at least 1 month

Intervention Type DRUG

Prednisone

5 mg per day p.o.

Intervention Type DRUG

Other Intervention Names

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CellCept mycophenolate mofetil mycophenolate sodium

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No