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

Phase 4 Completed 136 enrolled Novartis

RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start: 2006-07
Primary completion: 2008-09
Completion: 2008-09

Publications

Results Ortega F, Sanchez-Fructuoso A, Cruzado JM, Gomez-Alamillo JC, Alarcon A, Pallardo L, Morales JM, Oliver J, Guinea G; MYVIDA Study Group. Gastrointestinal quality of life improvement of renal transplant recipients converted from mycophenolate mofetil to enteric-coated mycophenolate sodium drugs or agents: mycophenolate mofetil and enteric-coated mycophenolate sodium. Transplantation. 2011 Aug 27;92(4):426-32. doi: 10.1097/TP.0b013e31822527ca.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Mycophenolate Mofetil	Small molecule	250 mg	—
Comparator	Mycophenolate Mofetil	Small molecule	500 mg	—
Subject	Mycophenolate Sodium	Unknown	1440 mg	—

Indications

No indication recorded.