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

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4

Details

• Lead Sponsor: Novartis
• Treatments: Cyclosporine; Cyclosporins; Mycophenolate mofetil; Mycophenolic Acid; Prednisone

Criteria

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.