NCT00157014

Canadian Cardiology de Novo Study: A Comparison Between Tacrolimus- and Cyclosporine- Based Immunoprophylactic Regimens

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and efficacy of tacrolimus in de novo heart transplantation.

Detailed description

Subcellular markers will be assessed in relationship to cellular acute rejection in de novo cardiac transplant recipients receiving either tacrolimus or cyclosporine as their primary immunosuppressant Two parallel active arms.

Conditions

• Heart Diseases
• Heart Transplantation

Interventions

Type	Name	Description
DRUG	Tacrolimus	Oral
DRUG	Cyclosporine	Oral
DRUG	Mycophenolate mofetil	Intravenous and Oral
DRUG	Methylprednisolone	Intravenous
DRUG	Prednisone	Oral

Timeline

• Start date: 2004-05-10
• Primary completion: 2008-07-18
• Completion: 2008-07-18
• First posted: 2005-09-12
• Last updated: 2017-06-05
• Results posted: 2011-02-21

Locations

13 sites across 2 countries: United States, Canada