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

Graft Failure Clinical Trial

— Veloxis  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03373227
• Other study ID #: 017-178
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 4, 2017
• Est. completion date: December 30, 2023

Study information

• Verified date: January 2023
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Compliance, Patient
• Graft Failure
• Heart Transplant Rejection

Intervention

Drug:
• Envarsus
Patients will take once daily Envarsus

Locations

Country	Name	City	State
United States	Baylor University Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rejection and Graft Failure	Evaluate effect on rejection and graft failure by comparing adverse events in standard of care versus experimental groups	2 years
Secondary	Effect of Compliance on Rejection and Graft Failure	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	2 years