Efficacy and Safety of AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Steroids in Preventing Acute Rejection After Kidney Transplantation

Phase 1/2 Completed 124 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupOpen-labelTreatment

Summary

Efficacy and safety of AEB071 in combination with mycophenolate acid sodium, basiliximab and steroids in preventing acute rejection after kidney transplantation.

Timeline

Start: 2007-01
Primary completion: 2008-05
Completion: —

Outcome

Missed primary endpoint

paper Composite efficacy failure at month 3 was higher for the sotrastaurin versus control regimen (25.7% vs. 4.5%, p = 0.001) PMID 21564523 ↗

Publications

Friman S, Arns W, Nashan B, Vincenti F, Banas B, Budde K, Cibrik D, Chan L, Klempnauer J, Mulgaonkar S, Nicholson M, Wahlberg J, Wissing KM, Abrams K, Witte S, Woodle ES. Sotrastaurin, a novel small molecule inhibiting protein-kinase C: randomized phase II study in renal transplant recipients. Am J Transplant. 2011 Jul;11(7):1444-55. doi: 10.1111/j.1600-6143.2011.03538.x. Epub 2011 May 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	sotrastaurin	Small molecule	300 mg	Oral

Indications

No indication recorded.