Evaluation of the Therapeutic Benefit of an Initial Intensified Dosing Regimen of Mycophenolate Sodium Versus a Standard Regimen in Renal Transplant Patients

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

313 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2009-06-30

Brief Summary

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The purpose of this study is to determine if an initial intensified enteric-coated mycophenolate sodium (Myfortic) dosing regimen administered during the first six weeks post renal transplantation provides improved efficacy, with a similar safety profile, compared to a standard regimen of Myfortic.

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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

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intensified Mycophenolate Sodium (Myfortic) dosing regimen

In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.

Group Type EXPERIMENTAL

Enteric-coated mycophenolate sodium (Myfortic)

Intervention Type DRUG

1440 mg/day for the standard dose. 2880 mg/day for the initial intensified dosage, reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.

Cyclosporine (Neoral)

Intervention Type DRUG

cyclosporine microemulsion in galenic form capsules starting at twice a day for a dose of 8-10 mg/kg/day adjusted if necessary to achieve protocol specific target levels

Prednisone

Intervention Type DRUG

20 mg orally per day reduced according to center practice for a minimum dose of 5 mg/day.

Standard Mycophenolate Sodium (Myfortic) dosing regimen

In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440 mg/day had to be maintained throughout the whole study.

Group Type ACTIVE_COMPARATOR

Enteric-coated mycophenolate sodium (Myfortic)

Intervention Type DRUG

1440 mg/day for the standard dose. 2880 mg/day for the initial intensified dosage, reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.

Cyclosporine (Neoral)

Intervention Type DRUG

cyclosporine microemulsion in galenic form capsules starting at twice a day for a dose of 8-10 mg/kg/day adjusted if necessary to achieve protocol specific target levels

Prednisone

Intervention Type DRUG

20 mg orally per day reduced according to center practice for a minimum dose of 5 mg/day.

Interventions

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Enteric-coated mycophenolate sodium (Myfortic)

1440 mg/day for the standard dose. 2880 mg/day for the initial intensified dosage, reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.

Intervention Type DRUG

Cyclosporine (Neoral)

cyclosporine microemulsion in galenic form capsules starting at twice a day for a dose of 8-10 mg/kg/day adjusted if necessary to achieve protocol specific target levels

Intervention Type DRUG

Prednisone

20 mg orally per day reduced according to center practice for a minimum dose of 5 mg/day.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males or females, 18 to 65 years old
* First or second time kidney transplant patients
* For females capable of becoming pregnant, negative pregnancy test prior to entry into trial and effective birth control during trial and 3 months after stopping trial medication

Exclusion Criteria

* Previous graft loss due to immunological reasons in the 1st year after the 1st transplant
* Multi-organ recipients or previous transplant of another organ, different from the kidney
* Recipients from a non-heart-beating donor
* Known hypersensitivity to mycophenolic acid or cyclosporine
* HIV positive or Hepatitis B surface antigen positive
* History of malignancy (past 5 years)
* Pregnancy or planned pregnancy, lactating, or unwillingness to use effective contraception.
* Evidence of severe liver disease

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No