NCT00284934

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

A Multicenter, National, Open-label, Prospective, Randomized Study to Evaluate Efficacy and Tolerability of Enteric-coated Mycophenolate Sodium 1440 mg/Day With Tacrolimus Reduced Dose Versus Enteric-coated Mycophenolate Sodium 720 mg/Day With Tacrolimus Standard Dose, in Maintenance, Stable, Adult, Kidney Transplant Recipients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Diseases

Interventions

Type	Name	Description
DRUG	Enteric-coated mycophenolate sodium (EC-MPS)
DRUG	Tacrolimus
DRUG	Corticosteroids	At a dose of at least 5 mg/day.

Timeline

• Start date: 2005-12-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2006-02-01
• Last updated: 2011-05-02
• Results posted: 2011-05-02

Locations

1 site across 1 country: Switzerland