Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02545972
Recruitment Status : Unknown
Verified September 2016 by David A. Baran, MD, Newark Beth Israel Medical Center.
Recruitment status was:  Recruiting
First Posted : September 10, 2015
Last Update Posted : September 21, 2016
Sponsor:
Information provided by (Responsible Party):
David A. Baran, MD, Newark Beth Israel Medical Center

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.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: tacrolimus extended release Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Non-randomized Trial of Conversion From Twice a Day Tacrolimus to Once Daily Modified Release Tacrolimus
Study Start Date : February 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

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 Name: Astagraf




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02545972


Contacts
Layout table for location contacts
Contact: David A Baran, MD 973-926-7205 dbaran@barnabashealth.org

Locations
Layout table for location information
United States, New Jersey
Newark Beth Israel Medical Center Recruiting
Newark, New Jersey, United States, 07112
Contact: David Baran, MD    973-926-7205    dbaran@barnabashealth.org   
Contact: Mark Zucker, MD, JD    973-926-7205    mzucker@barnabashealth.org   
Sponsors and Collaborators
Newark Beth Israel Medical Center
Investigators
Layout table for investigator information
Principal Investigator: David A Baran, MD Newark Beth Israel Medical Center

Layout table for additonal information
Responsible Party: David A. Baran, MD, Director, Heart Failure & Transplant Research, Newark Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT02545972     History of Changes
Other Study ID Numbers: OneTAC
First Posted: September 10, 2015    Key Record Dates
Last Update Posted: September 21, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by David A. Baran, MD, Newark Beth Israel Medical Center:
immunosuppression
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action