A Study to Assess the Efficacy and Safety of Alefacept in Kidney Transplant Recipients

Phase 2 Completed 218 enrolled Astellas Pharma Inc

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of this study is to determine whether alefacept is effective and well tolerated when used with a combination of tacrolimus, mycophenolate mofetil and steroids versus a combination therapy of placebo, tacrolimus and steroids in the prevention of kidney transplant rejection.

Timeline

Start: 2007-12
Primary completion: 2009-09
Completion: 2009-09

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alefacept	Protein / enzyme biologic	15 mg	Intravenous
Background	Methylprednisolone	Other / unclassified	125 mg	Intravenous
Background	Methylprednisolone	Other / unclassified	250 mg	Intravenous
Background	Methylprednisolone	Other / unclassified	500 mg	Intravenous
Background	Methylprednisolone	Other / unclassified	1000 mg	Intravenous
Background	Mycophenolate Mofetil	Small molecule	750 mg	Oral
Background	Prednisone	Other / unclassified	5 mg	Oral
Background	Prednisone	Other / unclassified	10 mg	Oral
Background	Prednisone	Other / unclassified	15 mg	Oral
Background	Prednisone	Other / unclassified	20 mg	Oral
Background	Prednisone	Other / unclassified	30 mg	Oral
Background	Tacrolimus	Small molecule	0.2 mg/kg	Oral

Indications

No indication recorded.