Once-a-day Tacrolimus Conversion Study: The OneTAC Trial — OneTAC  

Heart Failure Clinical Trial

Official title: A Prospective Non-randomized Trial of Conversion From Twice a Day Tacrolimus to Once Daily Modified Release Tacrolimus

Status Recruiting

Clinical Trial Summary

This study investigates the use of tacrolimus extended release in stable patients who have undergone a heart transplant. All patients will receive the study medication free of charge for the 1 year duration of the study.

Clinical Trial Description

Tacrolimus has been extensively studied in solid organ transplantation. It is FDA approved for heart transplant recipients as a twice a day formulation (Prograf brand name, as well as generic formulations). A modified release formulation is available and FDA approved for kidney transplant recipients (Astagraf, Astellas Pharmaceutical), but is not approved for heart transplant patients.

In this study the investigators will study 100 patients who are stable on twice a day Tacrolimus and convert these subjects to once a day modified release Tacrolimus. The investigators will observe these patients for 1 year following the switch and assess safety and efficacy in a heart transplant population. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

• NCT number: NCT02545972
• Study type: Interventional
• Source: Newark Beth Israel Medical Center
• Contact: David A Baran, MD
• Phone: 973-926-7205
• Email: dbaran@barnabashealth.org
• Status: Recruiting
• Phase: Phase 4
• Start date: February 2016
• Completion date: February 2019