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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Once a day tacrolimus | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tacrolimus extended release | Drug | daily dosing of tacrolimus |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David A Baran, MD | Contact | 973-926-7205 | dbaran@barnabashealth.org |
| Name | Affiliation | Role |
|---|---|---|
| David A Baran, MD | Newark Beth Israel Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Newark Beth Israel Medical Center | Recruiting | Newark | New Jersey | 07112 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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