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

September 20, 2016 updated by: David A. Baran, MD, Newark Beth Israel Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Astagraf

What is the study measuring?

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.
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
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.
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Newark Beth Israel Medical Center

Investigators

  • Principal Investigator: David A Baran, MD, Newark Beth Israel Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

November 1, 2018

Study Completion (Anticipated)

February 1, 2019

Study Registration Dates

First Submitted

September 7, 2015

First Submitted That Met QC Criteria

September 8, 2015

First Posted (Estimate)

September 10, 2015

Study Record Updates

Last Update Posted (Estimate)

September 21, 2016

Last Update Submitted That Met QC Criteria

September 20, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OneTAC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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