NCT00419926

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

A Randomized, Multicenter, Parallel-group, Open-label Study to Evaluate the Therapeutic Benefit of an Initially Intensified Dosing Regimen of Mycophenolate Sodium Versus a Standard Dosing Regimen, in Combination With Cyclosporine and Corticosteroids in de Novo Renal Transplant Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 313 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: —

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.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	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.
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
DRUG	Prednisone	20 mg orally per day reduced according to center practice for a minimum dose of 5 mg/day.

Timeline

• Start date: 2006-12-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2007-01-09
• Last updated: 2011-03-01
• Results posted: 2011-01-11

Locations

1 site across 1 country: Switzerland