At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 501 enrolled
Drug / intervention
basiliximab +5 moredrug
Likely dose
Not stated in record
Key inclusion· 2
- ✓Primary or re-transplanted deceased donor kidney
- ✓Primary or re-transplanted living donor kidney (HLA identical or 0 antigen mismatch)
Key exclusion· 2
- ✕Prior organ transplant other than kidney
- ✕Chronic steroid therapy at time of transplant
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating basiliximab, rabbit anti-thymocyte globulin, and 4 other interventions for Kidney Transplantation. Completed, enrolled 501 participants across 29 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Transplantation
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2005
First PostedJun 2005
Primary CompletionMar 2009
TodayJul 2026
First PostedJun 8, 2005
Enrollment StartMay 1, 2005
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 21.1 years ago
Interventions
basiliximabdrug
IV
rabbit anti-thymocyte globulindrug
IV
tacrolimusdrug
oral
alemtuzumabdrug
Intravenous (IV)
mycophenolate mofetildrug
oral
steroidsdrug
IV and/or oral