NCT00267150

Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Simultaneous Pancreas-Kidney Transplants

Measurement of Patient Reported Gastrointestinal (GI) and Health-related Quality of Life (HRQL) Outcomes in Simultaneous Pancreas-Kidney Transplant Recipients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will assess if a switch from MMF to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI and/or health-related quality of life outcomes and determine the proportion of pancreas-kidney transplant recipients who experience any GI complaints under MMF-based immunosuppressive treatment.

Conditions

• Pancreas Transplantation
• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	Enteric-coated mycophenolate sodium (EC-MPS)	Experimental

Timeline

• Start date: 2005-11-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2005-12-20
• Last updated: 2011-05-20
• Results posted: 2010-12-24

Locations

1 site across 1 country: Germany