Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients
NCT00113269 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 501
Last updated 2011-08-11
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.
Conditions
- Kidney Transplantation
Interventions
- DRUG
-
basiliximab
IV
- DRUG
-
rabbit anti-thymocyte globulin
IV
- DRUG
-
oral
- DRUG
-
alemtuzumab
Intravenous (IV)
- DRUG
-
mycophenolate mofetil
oral
- DRUG
-
steroids
IV and/or oral
Sponsors & Collaborators
-
Astellas Pharma Inc
lead INDUSTRY
Principal Investigators
-
Central Contact · Astellas Pharma Global Development
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-05-31
- Primary Completion
- 2009-03-31
- Completion
- 2009-03-31
Countries
- United States
Study Locations
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