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

Phase 4

• Conditions: Heart Failure
• Interventions: Drug: tacrolimus extended release

• Registration Number: NCT02545972
• Lead Sponsor: Newark Beth Israel Medical Center

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.

Study Timeline

• Study First Submitted: 2015-09-07
• Study First Submitted QC: 2015-09-08
• Study First Posted: 2015-09-10
• Study Start: 2016-02
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-09-21
• Primary Completion: 2018-11
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Once a day tacrolimus	tacrolimus extended release	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.

Primary Outcome Measures

Name	Time	Method
The change in glomerular filtration rate slope between the 6 months prior to study enrollment and 6 months post-study enrollment.	6 months	The change in the slope of the Glomerular filtration rate at 6 months prior to study enrollment as compared to 6 months post study enrollment

Secondary Outcome Measures

Name	Time	Method
The change in glomerular filtration rate slope between the 6 months prior to study enrollment and 12 months post-study enrollment.	12 months	The change in the slope of the Glomerular filtration rate at 6 months prior to study enrollment as compared to 12 months post study enrollment

Trial Locations

Locations (1)

Newark Beth Israel Medical Center; 🇺🇸 Newark, New Jersey, United States