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

Novartis

Status and phase: Completed; Phase 4

Conditions: Kidney Transplantation

Treatments: Drug: Cyclosporine (Neoral); Drug: Enteric-coated mycophenolate sodium (Myfortic); Drug: Prednisone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00419926

CERL080A2419

Details and patient eligibility

About

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.

Enrollment: 313 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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313 participants in 2 patient groups

Intensified Mycophenolate Sodium (Myfortic) dosing regimen

Experimental group

Description:

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.

Treatment:

Drug: Prednisone

Drug: Enteric-coated mycophenolate sodium (Myfortic)

Drug: Cyclosporine (Neoral)

Standard Mycophenolate Sodium (Myfortic) dosing regimen

Active Comparator group

Description:

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

Treatment:

Drug: Prednisone

Drug: Enteric-coated mycophenolate sodium (Myfortic)

Drug: Cyclosporine (Neoral)