Safety and Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) Plus Valsartan in Patients With Kidney Transplants (MYTHOS

Phase 3 Completed 119 enrolled Novartis

RandomizedParallel-groupOpen-labelPrevention

Summary

The primary aim of this study is to evaluate the safety and efficacy of EC-MPS plus valsartan as part of an intensified multifactorial intervention on the reduction of the 12-month rate of transplant nephropathy compared with EC-MPS plus standard practice of care in recipients of a first cadaver donor kidney transplant given CsA-ME, basiliximab, and short-term steroids.

Timeline

Start: 2002-10
Primary completion: 2005-06
Completion: 2005-06

Publications

Natale P, Mooi PK, Palmer SC, Cross NB, Cooper TE, Webster AC, Masson P, Craig JC, Strippoli GF. Antihypertensive treatment for kidney transplant recipients. Cochrane Database Syst Rev. 2024 Jul 31;7(7):CD003598. doi: 10.1002/14651858.CD003598.pub3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Valsartan	Small molecule	—	—
Background	Mycophenolate Sodium	Unknown	—	—

Indications

No indication recorded.