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

Primary Purpose

Heart Failure

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
tacrolimus extended release
Sponsored by
Newark Beth Israel Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring immunosuppression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Newark Beth Israel Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Once a day tacrolimus

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 7, 2015
Last Updated
September 20, 2016
Sponsor
Newark Beth Israel Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02545972
Brief Title
Once-a-day Tacrolimus Conversion Study: The OneTAC Trial
Acronym
OneTAC
Official Title
A Prospective Non-randomized Trial of Conversion From Twice a Day Tacrolimus to Once Daily Modified Release Tacrolimus
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Newark Beth Israel Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
immunosuppression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Once a day tacrolimus
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
tacrolimus extended release
Other Intervention Name(s)
Astagraf
Intervention Description
daily dosing of tacrolimus
Primary Outcome Measure Information:
Title
The change in glomerular filtration rate slope between the 6 months prior to study enrollment and 6 months post-study enrollment.
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The change in glomerular filtration rate slope between the 6 months prior to study enrollment and 12 months post-study enrollment.
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David A Baran, MD
Phone
973-926-7205
Email
dbaran@barnabashealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Baran, MD
Organizational Affiliation
Newark Beth Israel Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Baran, MD
Phone
973-926-7205
Email
dbaran@barnabashealth.org
First Name & Middle Initial & Last Name & Degree
Mark Zucker, MD, JD
Phone
973-926-7205
Email
mzucker@barnabashealth.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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