Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients

Phase 4 Completed 30 enrolled Novartis

Non-randomizedSingle-groupOpen-labelPrevention

Summary

Clinical trial for the novo transplant recipients, which aims to assess tolerability and safety and clinical outcomes of EC-MPS in combination with cyclosporine microemulsion (CsA-ME) with or without steroids in a population of kidney transplant recipients.

Timeline

Start: 2005-02
Primary completion: 2006-06
Completion: 2006-06

Publications

Results Wyzgal J, Niemczyk M, Ziolkowski J, Durlik M, Wiecek A. Results of a 6-month, multicenter, open-label, prospective study concerning efficacy and safety of mycophenolate sodium in de novo kidney transplant recipients. Transplant Proc. 2007 Nov;39(9):2730-2. doi: 10.1016/j.transproceed.2007.08.071.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mycophenolate Sodium	Unknown	—	—

Indications

No indication recorded.