NCT00238940

Extension Study of Enteric-coated Mycophenolate Sodium in Combination With Full Dose or Reduced Dose Cyclosporine Microemulsion in Patients With de Novo Kidney Transplants

A One-year, Randomized, Open Label, Parallel Group Study to Investigate the Safety and the Effect of Enteric-coated Mycophenolate Sodium (EC-MPS) in Combination With Either Full Dose or Reduced Dose Cyclosporine Microemulsion in de Novo Kidney Transplant Recipients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

Summary

This extension study is considered to allow patients being treated with EC-MPS to collect further information on the long-term safety of this drug.

Conditions

• Renal Transplantation

Interventions

Type	Name	Description
DRUG	Enteric-Coated Mycophenolate Sodium (EC-MPS)

Timeline

• Start date: 2003-02-01
• Primary completion: 2005-09-01
• Completion: 2005-09-01
• First posted: 2005-10-14
• Last updated: 2011-01-31