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

Sponsor

Baylor Research Institute (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03373227

Collaborator

(none)

Enrollment

Location

Arms

59.9

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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

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 :

Dec 4, 2017

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 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.

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

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

Secondary Outcome Measures

Effect of Compliance on Rejection and Graft Failure [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

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Baylor Research Institute

ClinicalTrials.gov Identifier:

NCT03373227

Other Study ID Numbers:

017-178

First Posted:

Dec 14, 2017

Last Update Posted:

Jul 30, 2020

Last Verified:

Jul 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Baylor Research Institute

Heart Transplant

Additional relevant MeSH terms:

Tacrolimus

Study Results

No Results Posted as of Jul 30, 2020