NCT00400400

Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance

A 4-week, Multicenter, Double-blind, Double-dummy, Randomized, Parallel Group Study to Compare the Gastrointestinal Safety and Tolerability of EC-MPS & MMF When Administered in Combination With Calcineurin Inhibitors in Renal Transplant Recipients Experiencing Gastrointestinal Intolerance

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will investigate the safety and tolerability of converting kidney transplant recipients with gastrointestinal symptoms from their current treatment of mycophenolate mofetil (MMF) to treatment with enteric-coated mycophenolate sodium (EC-MPS).

Conditions

• Renal Transplantation

Interventions

Type	Name	Description
DRUG	Enteric-coated mycophenolate sodium (EC-MPS)	Enteric-coated mycophenolate sodium supplied as 180 mg tablets.
DRUG	Mycophenolate mofetil	Mycophenolate mofetil supplied as 250 mg capsules.
DRUG	Placebo to mycophenolate sodium	Placebo to mycophenolate sodium matching tablets.
DRUG	Placebo to mycophenolate mofetil	Placebo to mycophenolate mofetil matching capsules.

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-06-01
• First posted: 2006-11-16
• Last updated: 2011-08-15
• Results posted: 2011-08-15

Locations

53 sites across 1 country: United States