Once-a-day Tacrolimus Conversion Study: The OneTAC Trial (OneTAC)
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|ClinicalTrials.gov Identifier: NCT02545972|
Recruitment Status : Unknown
Verified September 2016 by David A. Baran, MD, Newark Beth Israel Medical Center.
Recruitment status was: Recruiting
First Posted : September 10, 2015
Last Update Posted : September 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Drug: tacrolimus extended release||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Non-randomized Trial of Conversion From Twice a Day Tacrolimus to Once Daily Modified Release Tacrolimus|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||February 2019|
Experimental: 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.
Drug: tacrolimus extended release
daily dosing of tacrolimus
Other Name: Astagraf
- The change in glomerular filtration rate slope between the 6 months prior to study enrollment and 6 months post-study enrollment. [ Time Frame: 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
- The change in glomerular filtration rate slope between the 6 months prior to study enrollment and 12 months post-study enrollment. [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02545972
|Contact: David A Baran, MDfirstname.lastname@example.org|
|United States, New Jersey|
|Newark Beth Israel Medical Center||Recruiting|
|Newark, New Jersey, United States, 07112|
|Contact: David Baran, MD 973-926-7205 email@example.com|
|Contact: Mark Zucker, MD, JD 973-926-7205 firstname.lastname@example.org|
|Principal Investigator:||David A Baran, MD||Newark Beth Israel Medical Center|