Study of Enteric-coated Mycophenolate Sodium (EC-MPS) With Cyclosporine Microemulsion and Steroids in Pediatric de Novo Renal Transplant Patients

Phase 4 Completed 15 enrolled Novartis Pharmaceuticals

Non-randomizedSingle-groupOpen-labelPrevention

Summary

The aim of this pilot study is to evaluate efficacy and tolerability of EC-MPS b.i.d, with Cyclosporine microemulsion and steroids in pediatric de novo renal transplant patients. Safety and doses variations are also evaluated.

Timeline

Start: 2004-09
Primary completion: 2007-01
Completion: —

Publications

Background Niaudet P, Charbit M, Loirat C, Lapeyraque AL, Tsimaratos M, Cailliez M, Foulard M, Dehennault M, Marquet P, Chaouche-Teyara K, Lemay D. Enteric-coated mycophenolate sodium in de novo pediatric renal transplant patients. Pediatr Nephrol. 2009 Feb;24(2):395-402. doi: 10.1007/s00467-008-1031-7. Epub 2008 Nov 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mycophenolate Sodium	Unknown	—	—

Indications

No indication recorded.