Efficacy, Safety and Tolerability of AEB071 Versus Cyclosporine in the Novo Renal Transplant Recipients

Phase 2 Completed 311 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupOpen-labelTreatment

Summary

This study will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free (calcineurin inhibitor) regimen in renal transplant recipients.

Timeline

Start: 2007-07
Primary completion: 2011-04
Completion: 2011-04

Publications

Results Tedesco-Silva H, Kho MM, Hartmann A, Vitko S, Russ G, Rostaing L, Budde K, Campistol JM, Eris J, Krishnan I, Gopalakrishnan U, Klupp J. Sotrastaurin in calcineurin inhibitor-free regimen using everolimus in de novo kidney transplant recipients. Am J Transplant. 2013 Jul;13(7):1757-68. doi: 10.1111/ajt.12255. Epub 2013 May 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Cyclosporine	Peptide	—	—
Comparator	sotrastaurin	Small molecule	200 mg	Oral
Comparator	sotrastaurin	Small molecule	300 mg	Oral
Comparator	Everolimus	Small molecule	—	—

Indications

No indication recorded.