At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 111 enrolled
Drug / intervention
Tacrolimus +4 moredrug
Likely dose
Tacrolimus or Cyclosporine oral with Mycophenolate mofetil (intravenous and oral), Methylprednisolone (intravenous), and Prednisone (oral) — specific doses not statedAI-extracted
Key inclusion· 4
- ✓Primary cadaveric heart transplant recipients
- ✓Capable of understanding study purpose and risks, and willing to follow protocol
- ✓Able to tolerate oral medication and no gastrointestinal condition likely to affect absorption or metabolism of study drugs
- ✓Females of childbearing potential must have negative pregnancy test and agree to effective birth control
Key exclusion· 10
- ✕Previous organ transplant or multi-organ transplant recipients
- ✕Heart donor with incompatible ABO blood type
- ✕Significant graft dysfunction and/or significant de novo infection(s) at time of randomization
- ✕Known hypersensitivity to tacrolimus, cyclosporine, mycophenolate mofetil, daclizumab, prednisone, or excipients (cremophor, polysorbate 80, polyoxyl 60 hydrogenated castor oil)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical and Laboratory Evaluation of Acute Rejection, Myocyte Growth, Repair, and Oxidative Stress Following de Novo Cardiac Transplant: A Comparison Between Tacrolimus- and Cyclosporine- Based Immunoprophylactic Regimens With MPA TDM
In Brief
A Phase 3 clinical trial evaluating Tacrolimus, Cyclosporine, and 3 other interventions for Heart Diseases and Heart Transplantation. Completed, enrolled 111 participants across 13 sites in 2 countries.
Detailed Summary
The purpose of this study is to assess the safety and efficacy of tacrolimus in de novo heart transplantation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Diseases, Heart Transplantation
CountriesCanada, United States
CollaboratorsAstellas Pharma Canada, Inc.
Timeline
Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2004
First PostedSep 2005
Primary CompletionJul 2008
TodayJul 2026
First PostedSep 12, 2005
Enrollment StartMay 10, 2004
Primary CompletionJul 18, 2008
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 20.8 years ago
Interventions
Tacrolimusdrug
Oral
Cyclosporinedrug
Oral
Mycophenolate mofetildrug
Intravenous and Oral
Methylprednisolonedrug
Intravenous
Prednisonedrug
Oral