Non-inferiority Study of Safety and Efficacy of Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in Kidney Transplant Recipients

Phase 3 Completed 613 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this phase 3b study is to compare the safety and efficacy of everolimus with low dose tacrolimus to mycophenolate mofetil with standard dose tacrolimus in kidney transplant recipients.

Timeline

Start: 2010-01
Primary completion: 2013-03
Completion: 2013-03

Publications

Shihab F, Qazi Y, Mulgaonkar S, McCague K, Patel D, Peddi VR, Shaffer D. Association of Clinical Events With Everolimus Exposure in Kidney Transplant Patients Receiving Low Doses of Tacrolimus. Am J Transplant. 2017 Sep;17(9):2363-2371. doi: 10.1111/ajt.14215. Epub 2017 Mar 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Everolimus	Small molecule	0.75 mg	—
Comparator	Mycophenolate Mofetil	Small molecule	1 g	—
Subject	Tacrolimus	Small molecule	—	—

Indications

No indication recorded.