Recruiting

Tacrolimus

Sponsor:

Newark Beth Israel Medical Center

Code:

NCT02545972

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

tacrolimus extended release

Study Details

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.

Conditions

Heart Failure

Study ID

NCT02545972

Start date

Feb, 2016

Status verified date

Sep, 2016

Completion date

Feb, 2019

Anticipated

Primary completion date

Nov, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

tacrolimus extended release

daily dosing of tacrolimus

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

David A Baran, MD

973-926-7205dbaran@barnabashealth.org

Locations

Newark Beth Israel Medical Center

Recruiting

Newark, New Jersey, United States, 07112

Contacts

David Baran, MD

973-926-7205dbaran@barnabashealth.org

Mark Zucker, MD, JD

973-926-7205mzucker@barnabashealth.org

More Information

Sponsor

Newark Beth Israel Medical Center

Last update posted

Sep 21, 2016

Last verified

Sep, 2016

Keywords

  • immunosuppression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Newark Beth Israel Medical Center on 2016-09-21.