Efficacy, Safety, Tolerability, and Pharmacokinetics of Sotrastaurin Combined With Tacrolimus vs. a Mycophenolic Acid-tacrolimus Regimen in Renal Transplant Patients

Phase 2 Completed 298 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupQuadruple-blindPrevention

Summary

This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo renal transplantation.

Timeline

Start: 2009-12
Primary completion: 2012-08
Completion: 2012-08

Publications

Results Russ GR, Tedesco-Silva H, Kuypers DR, Cohney S, Langer RM, Witzke O, Eris J, Sommerer C, von Zur-Muhlen B, Woodle ES, Gill J, Ng J, Klupp J, Chodoff L, Budde K. Efficacy of sotrastaurin plus tacrolimus after de novo kidney transplantation: randomized, phase II trial results. Am J Transplant. 2013 Jul;13(7):1746-56. doi: 10.1111/ajt.12251. Epub 2013 May 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tacrolimus	Small molecule	—	—
Comparator	mycophenolic acid	Small molecule	720 mg	—
Subject	sotrastaurin	Small molecule	100 mg	Oral
Subject	sotrastaurin	Small molecule	200 mg	Oral
Subject	sotrastaurin	Small molecule	300 mg	Oral

Indications

No indication recorded.