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

NCT03373227 | Completed Phase 2 FDA Drug

• 1 other identifier: 017-178
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Transplant Rejection; Graft Failure; Compliance, Patient

Keywords

Heart Transplant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Effect of Compliance on Rejection and Graft Failure

  2 years

Study Arms (2)

Prospective

EXPERIMENTAL

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

Retrospective

NO INTERVENTION

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.

Interventions

Envarsus DRUG

Patients will take once daily Envarsus

Prospective

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Patient Compliance

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Shelley Hall, MD, FACC, FHFSA

  Baylor Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: December 14, 2017
• Study Start: December 4, 2017
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: October 8, 2025

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)