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

Heart Failure Clinical Trial

— OneTAC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02545972
• Other study ID #: OneTAC
• Status: Recruiting
• Phase: Phase 4
• First received: September 7, 2015
• Last updated: September 20, 2016
• Start date: February 2016
• Est. completion date: February 2019

Study information

• Verified date: September 2016
• Source: Newark Beth Israel Medical Center
• Contact: David A Baran, MD
• Phone: 973-926-7205
• Email: dbaran[@]barnabashealth.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• tacrolimus extended release
daily dosing of tacrolimus

Locations

Country	Name	City	State
United States	Newark Beth Israel Medical Center	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Newark Beth Israel Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes