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

Newark Beth Israel Medical Center

Status and phase

Unknown

Phase 4

Conditions

Heart Failure

Treatments

Drug: tacrolimus extended release

Study type

Interventional

Funder types

Other

Identifiers

NCT02545972

OneTAC

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult, age 18 or higher
Heart transplant recipient at least 365 days post-transplant at time of study screening
Informed consent available
Willingness to return for study visits, clinically indicated bloodwork
On tacrolimus-based chronic immunosuppression.
Self-identified ethnic group is provided

Exclusion criteria

Prior heart or solid organ transplant
Less than 365 days post-transplant at study screening
Receiving cyclosporine based immunosuppression or calcineurin inhibitor free regimen
Concurrent kidney or other solid organ
Inability to provide informed consent
More than 15 years post-transplant