Status:
COMPLETED
Phase II Study Evaluating the Efficacy of Tacrolimus Extended Release Tablets to Twice Daily Tacrolimus Dosing Regimen
Lead Sponsor:
Baylor Research Institute
Conditions:
Heart Transplant Rejection
Graft Failure
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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®) ...
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 transpl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03373227
Start Date
December 4 2017
End Date
December 30 2023
Last Update
October 8 2025
Active Locations (1)
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1
Baylor University Medical Center
Dallas, Texas, United States, 75246