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

NCT03373227 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-10-08

No results posted yet for this study

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

Interventions

DRUG

Envarsus

Patients will take once daily Envarsus

Sponsors & Collaborators

  • Baylor Research Institute

    lead OTHER

Principal Investigators

  • Shelley Hall, MD, FACC, FHFSA · Baylor Health Care System

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-04
Primary Completion
2023-12-30
Completion
2023-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03373227 on ClinicalTrials.gov