Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients

Phase 4 Completed 501 enrolled Astellas Pharma Inc

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, mycophenolate mofetil (MMF) and a rapid steroid withdrawal.

Timeline

Start: 2005-05
Primary completion: 2009-03
Completion: 2009-03

Publications

Background Hanaway MJ, Woodle ES, Mulgaonkar S, Peddi VR, Kaufman DB, First MR, Croy R, Holman J; INTAC Study Group. Alemtuzumab induction in renal transplantation. N Engl J Med. 2011 May 19;364(20):1909-19. doi: 10.1056/NEJMoa1009546.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alemtuzumab	Monoclonal antibody	—	Intravenous
Comparator	Basiliximab	Monoclonal antibody	—	—
Comparator	Thymoglobulin	Protein / enzyme biologic	—	—
Background	Mycophenolate Mofetil	Small molecule	—	Oral
Background	Tacrolimus	Small molecule	—	Oral

Indications

No indication recorded.