NCT03373227CompletedPhase 2
Phase II Study Evaluating the Efficacy of Tacrolimus Extended Release Tablets to Twice Daily Tacrolimus Dosing Regimen
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
Source: ClinicalTrials.gov · Last updated 8 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 5 Dec 2017
- Start date
- 4 Dec 2017
- Primary completion date
- 30 Dec 2023
- Lead sponsor
- Baylor Research Institute
- NCT number
- NCT03373227
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 50
- From 4 Dec 2017 to the primary completion date, 30 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Simultaneous multiple organ transplant recipients
- Liver transplant recipients / candidates
Other illness
- History of hypersensitivity/adverse reaction to tacrolimus
Other
- Subject currently enrolled in another interventional research trial
- Patient taking Rapamycin (sirolimus) or cyclosporine (Neoral/Gengraf)
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Baylor University Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.