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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: tacrolimus extended release


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Once a day tacrolimus<br>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. | Drug: tacrolimus extended release<br>* daily dosing of tacrolimus<br>* Other names: Astagraf;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in glomerular filtration rate slope between the 6 months prior to study enrollment and 6 months post-study enrollment. | 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in glomerular filtration rate slope between the 6 months prior to study enrollment and 12 months post-study enrollment. | 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 | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immunosuppression