NCT02545972

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Newark Beth Israel Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	tacrolimus extended release	daily dosing of tacrolimus

Timeline

• Start date: 2016-02-01
• Primary completion: 2018-11-01
• Completion: 2019-02-01
• First posted: 2015-09-10
• Last updated: 2016-09-21

Locations

1 site across 1 country: United States