NCT00149903

Study of Enteric-coated Mycophenolate Sodium Versus Mycophenolate Mofetil in Adult de Novo Renal Transplant Patients

Multicenter, Double-blind, Randomized, Parallel Group Study on Efficacy and Safety of Enteric-coated Mycophenolate Sodium vs. Mycophenolate Mofetil in de Novo Chinese Renal Transplant Recipients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (planned)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

Summary

Purpose of study is to compare the efficacy of enteric-coated mycophenolate sodium compared to mycophenolate mofetil in Chinese patients (study conducted in China) as measured by the incidence of biopsy proven acute rejection, graft loss, or death within six months of treatment in de novo renal transplant patients.

Conditions

• Renal Transplant

Interventions

Type	Name	Description
DRUG	Mycophenolate sodium (enteric coated)

Timeline

• Start date: 2005-01-01
• Primary completion: 2006-06-01
• First posted: 2005-09-08
• Last updated: 2016-11-18

Locations

1 site across 1 country: China