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

De Novo Kidney Transplantation Clinical Trial

Official title:
Efficacy and Safety of Alefacept in Combination With Tacrolimus, Mycophenolate Mofetil and Steroids in de Novo Kidney Transplantation - a Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

De Novo Kidney Transplantation

Clinical Trial Details

NCT number	NCT00617604
Study type	Interventional
Source	Astellas Pharma Inc
Contact
Status	Completed
Phase	Phase 2
Start date	December 2007
Completion date	September 2009

View Details

See also
	Status	Clinical Trial	Phase
	Completed	`NCT01742624` - Study to Evaluate the Safety and Efficacy of Advagraf vs Prograf in Kidney Transplantation Patients 1 Month After the Transplantation	Phase 4
	Completed	`NCT00239018` - Extension Study on the Efficacy and Safety of Enteric-coated Mycophenolate Sodium Administered in de Novo Kidney Transplant Patients	Phase 4