Phase II Study Evaluating the Efficacy of Tacrolimus Extended Release Tablets to Twice Daily Tacrolimus Dosing Regimen (Veloxis)

• ClinicalTrials.gov Identifier: NCT03373227
• Recruitment Status: Active, not recruiting
• First Posted: December 14, 2017
• Last Update Posted: July 30, 2020
• Sponsor: Baylor Research Institute
• Information provided by (Responsible Party): Baylor Research Institute

Study Description

Brief Summary:

This phase II, single-center, open-label study will evaluate the comparable efficacy of tacrolimus extended release tablets (Envarsus®) to the standard of care (SOC) twice daily tacrolimus (Prograf®) dosing regimen post-cardiac transplantation.

Condition or disease	Intervention/treatment	Phase
Heart Transplant Rejection; Graft Failure; Compliance, Patient	Drug: Envarsus	Phase 2

Detailed Description:

This is a prospective, open-label, 2-arm, clinical trial to evaluate the efficacy of extended release tacrolimus (Envarsus) once-daily in comparison to Prograf capsules twice-daily after heart transplantation receiving the standard of care twice daily dosing with tacrolimus (Prograf).

Secondary objectives are to compare the compliance, safety and efficacy of once a day dosing (Envarsus) versus twice a day dosing (Prograf) and to evaluate the short term safety and tolerability of Envarsus.

Approximately 25 adult male or female recipients of a heart transplant will be prospectively enrolled to once-daily therapy with Envarsus tablets. Time of initiation will follow current standard of care. In addition, 25 age/gender-matched subjects who are receiving twice daily dosing with Prograf will be identified from the transplant center database and contacted to be consented, after which their results will be analyzed retrospectively.

The Termination Visit will occur on Day 182 (± 2 days) for subjects who complete the study treatment. Subjects who receive the first dose of study drug but withdraw from the study or terminate study treatment for any reason should complete all the procedures outlined for the Termination Visit.

The follow-up safety assessment may be conducted via telephone or at a study visit if needed for clinical follow-up on any safety issues). The follow-up safety assessment is to take place approximately 30 days (±5 days) after the last administration of study treatment, whether the subject completed study treatment or withdrew or terminated treatment early.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II, Single-Center, Open-Label Study Evaluating the Comparable Efficacy of Tacrolimus Extended Release Tablets (Envarsus®) to the Standard of Care (SOC) Twice Daily Tacrolimus (Prograf®) Dosing Regimen
• Actual Study Start Date: December 4, 2017
• Estimated Primary Completion Date: December 2022
• Estimated Study Completion Date: December 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Prospective; 25 adult male or female recipients of a heart transplant will be prospectively enrolled to once-daily therapy with Envarsus tablets. Time of initiation will follow current standard of care.	Drug: Envarsus; Patients will take once daily Envarsus
No Intervention: Retrospective; 25 age/gender-matched subjects who are receiving twice daily dosing with Prograf will be identified from the transplant center database and contacted to be consented, after which their results will be analyzed retrospectively.

Outcome Measures

Primary Outcome Measures :

1. Rejection and Graft Failure [ Time Frame: 2 years ]
   Evaluate effect on rejection and graft failure by comparing adverse events in standard of care versus experimental groups

Secondary Outcome Measures :

1. Effect of Compliance on Rejection and Graft Failure [ Time Frame: 2 years ]
   To compare complications that lead to acute rejection and graft failure based on patient compliance to once a day dosing versus twice a day dosing

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Male or female, ≥ 18 years of age
• Able to comply with medication regimen
• Subjects must have the capacity to understand and sign the informed consent form
• Heart-only transplant recipients

Exclusion Criteria:

• Subject currently enrolled in another interventional research trial
• History of hypersensitivity/adverse reaction to tacrolimus
• Patient taking Rapamycin (sirolimus) or cyclosporine (Neoral/Gengraf)
• Simultaneous multiple organ transplant recipients
• Liver transplant recipients / candidates

Contacts and Locations

Locations

United States, Texas

Baylor University Medical Center

Dallas, Texas, United States, 75246

Sponsors and Collaborators

Baylor Research Institute

Investigators

• Principal Investigator: Shelley Hall, MD, FACC, FHFSA; Baylor Health Care System

More Information

• Responsible Party: Baylor Research Institute
• ClinicalTrials.gov Identifier: NCT03373227
• Other Study ID Numbers: 017-178
• First Posted: December 14, 2017
• Last Update Posted: July 30, 2020
• Last Verified: July 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Baylor Research Institute:

Heart Transplant

Additional relevant MeSH terms:

Tacrolimus; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Calcineurin Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action