Safety and Tolerability of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Patients With GI Intolerance

Phase 4 Completed 728 enrolled Novartis

Non-randomizedParallel-groupOpen-labelPrevention

Summary

The aim of this study is to evaluate the safety and tolerability of EC-MPS in maintenance renal transplant patients who experience gastrointestinal (GI) intolerance due to adverse events associated with mycophenolate mofetil (MMF) and were converted to EC-MPS.

Timeline

Start: 2004-10
Primary completion: 2006-02
Completion: —

Publications

Bolin P, Tanriover B, Zibari GB, Lynn ML, Pirsch JD, Chan L, Cooper M, Langone AJ, Tomlanovich SJ. Improvement in 3-month patient-reported gastrointestinal symptoms after conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in renal transplant patients. Transplantation. 2007 Dec 15;84(11):1443-51. doi: 10.1097/01.tp.0000290678.06523.95.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mycophenolate Sodium	Unknown	—	—

Indications

No indication recorded.