drugset / Trial / NCT00419926

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

NCT00419926

Phase 4 Completed 313 enrolled Novartis
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2006-12
Primary completion
2009-06
Completion
2009-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Mycophenolate Sodium Unknown 1440 mg
Background Cyclosporine Peptide 8 mg/kg
Background Cyclosporine Peptide 10 mg/kg
Background Prednisone Other / unclassified 5 mg Oral

Indications

No indication recorded.