NCT00658333

A Study Designed to Compare the Tolerability of an Increased Dose of Enteric-coated Mycophenolate Acid (MPA) in Renal Transplant Patients Whose Dose of Mycophenolate Mofetil (MMF) Was Reduced Due to Gastrointestinal Symptoms

A Multicenter, Randomized, Double Blind, Double Dummy Controlled Study to Assess the Tolerability of an Increased Dose of Enteric Coated MPA After Conversion From MMF in Renal Transplant Recipients Who Required MMF Dose Reductions Due to Gastrointestinal Symptoms

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To determine if conversion to enteric coated MPA allows an escalated dose of mycophenolic acid (MPA) to be tolerated in patients experiencing gastrointestinal (GI) symptoms

Conditions

• Renal Transplantation

Interventions

Type	Name	Description
DRUG	Enteric-coated Mycophenolate Acid (EC-MPA)
DRUG	Mycophenolate Mofetil (MMF)
DRUG	Placebo MMF
DRUG	Placebo EC-MPA

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2008-04-15
• Last updated: 2012-08-07
• Results posted: 2011-03-11

Locations

37 sites across 1 country: United States