Once-a-day Tacrolimus Conversion Study: The OneTAC Trial
OneTAC
A Prospective Non-randomized Trial of Conversion From Twice a Day Tacrolimus to Once Daily Modified Release Tacrolimus
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 heart-failure
Started Feb 2016
Typical duration for phase_4 heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2015
CompletedFirst Posted
Study publicly available on registry
September 10, 2015
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedSeptember 21, 2016
September 1, 2016
2.8 years
September 7, 2015
September 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
The change in glomerular filtration rate slope between the 6 months prior to study enrollment and 12 months post-study enrollment.
12 months
Study Arms (1)
Once a day tacrolimus
EXPERIMENTALTacrolimus extended release will be given at an initial once daily dose equivalent to the total daily dose of the twice a day Tacrolimus formulation.
Interventions
daily dosing of tacrolimus
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David A Baran, MD
Newark Beth Israel Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Heart Failure & Transplant Research
Study Record Dates
First Submitted
September 7, 2015
First Posted
September 10, 2015
Study Start
February 1, 2016
Primary Completion
November 1, 2018
Study Completion
February 1, 2019
Last Updated
September 21, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share