NCT00400647

Gastrointestinal and Health-related Quality of Life in Kidney Transplant Patients Treated With Mycophenolate Mofetil

A 12-week Multicenter, Randomized, Open Study to Evaluate the Effects of Enteric-coated Mycophenolate Sodium (EC-MPS) in Terms of Quality of Life in Patients With Gastrointestinal (GI) Symptoms Treated With MMF (Mycophenolate Mofetil) After Kidney Transplant.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the quality of life in renal transplant recipients who require a reduced dose of mycophenolate mofetil (MMF) because of gastrointestinal (GI) side effects and will also access the relationship between mycophenolic acid (MPA) dose in those patients receiving enteric-coated mycophenolate sodium formulation(EC-MPS). Patients will be evaluated at baseline, 2 weeks after study medicine conversion and then again at 12 weeks post-conversion.

Conditions

• Maintenance Kidney Transplant

Interventions

Type	Name	Description
DRUG	Enteric-coated Mycophenolate sodium (EC-MPS)
DRUG	Mycophenolate mofetil

Timeline

• Start date: 2006-07-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2006-11-17
• Last updated: 2017-02-07

Locations

1 site across 1 country: Switzerland