NCT00113269

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

Phase 4, Randomized, Open-label, Comparative, Multicenter Study to Assess the Safety and Efficacy of Induction Agents, Alemtuzumab, Basiliximab or Rabbit Anti-thymocyte Globulin in Combination With Tacrolimus, MMF, and a Rapid Steroid Withdrawal in Renal Transplant Recipients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 501 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A 2 arm (1 Active, 1 Active Control) 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, MMF and a rapid steroid withdrawal.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	basiliximab	IV
DRUG	rabbit anti-thymocyte globulin	IV
DRUG	tacrolimus	oral
DRUG	alemtuzumab	Intravenous (IV)
DRUG	mycophenolate mofetil	oral
DRUG	steroids	IV and/or oral

Timeline

• Start date: 2005-05-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2005-06-08
• Last updated: 2011-08-11
• Results posted: 2011-07-08

Locations

29 sites across 1 country: United States