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

Status unconfirmed · Phase 4

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT02545972

Run by

Newark Beth Israel Medical Center

People needed

100

Starts

2016-02-01

Expected to finish

2019-02-01

Last updated by the study team

2016-09-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Newark Beth Israel Medical Center — Newark, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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