drugset / Trial / NCT00284934

Enteric-coated Mycophenolate Sodium (EC-MPS) With Reduced-dose Tacrolimus Versus EC-MPS With Standard-dose Tacrolimus in Stable Kidney Transplant Recipients

NCT00284934

Phase 3 Completed 94 enrolled Novartis
RandomizedParallel-groupOpen-labelTreatment

Summary

This study introduces a new optimization immunosuppressive regimen associating tacrolimus at a reduced dose and enteric-coated mycophenolate sodium at an increased dose in order to slow down renal function worsening and to prevent the progression of chronic allograft nephropathy, while maintaining the same efficacy, in maintenance renal transplant recipients.

Timeline

Start
2005-12
Primary completion
2008-06
Completion
2008-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Tacrolimus Small molecule Oral
Subject mycophenolic acid Small molecule 720 mg Oral
Subject mycophenolic acid Small molecule 1440 mg Oral
Background Prednisone Other / unclassified 5 mg Oral

Indications