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

• Status: Unknown status
• Trial end date: 2019-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Newark Beth Israel Medical Center
• Treatments: Tacrolimus

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