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

NCT ID: NCT02545972

Last Updated: 2016-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2019-02-28

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Once a day tacrolimus

Tacrolimus extended release will be given at an initial once daily dose equivalent to the total daily dose of the twice a day Tacrolimus formulation.

Group Type: EXPERIMENTAL

tacrolimus extended release

Intervention Type: DRUG

daily dosing of tacrolimus

Interventions

tacrolimus extended release

daily dosing of tacrolimus

Intervention Type: DRUG

Other Intervention Names

Astagraf

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Newark Beth Israel Medical Center

OTHER

Sponsor Role: lead

Responsible Party

David A. Baran, MD

Director, Heart Failure & Transplant Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David A Baran, MD

Role: PRINCIPAL_INVESTIGATOR

Newark Beth Israel Medical Center

Locations

Newark Beth Israel Medical Center

Newark, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

David A Baran, MD

Role: CONTACT

dbaran@barnabashealth.org

973-926-7205

Facility Contacts

David Baran, MD

Role: primary

dbaran@barnabashealth.org

973-926-7205

Mark Zucker, MD, JD

Role: backup

mzucker@barnabashealth.org

973-926-7205

Other Identifiers

OneTAC

Identifier Type: -

Identifier Source: org_study_id