Heart Transplant RejectionPhase 2VeloxisNCT03373227
Phase II Study Evaluating the Efficacy of Tacrolimus Extended Release Tablets to Twice Daily Tacrolimus Dosing Regimen
A Phase 2 study testing Envarsus in people with Heart Transplant Rejection and Graft Failure, run by Baylor Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Transplant Rejection, Graft Failure, Compliance, Patient
- What is being tested?
- Envarsus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2017to 30 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor University Medical Center
Dallas, Texas, 75246
About this study
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
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.
Read the 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 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.
- Being tested
- Envarsus
- Keywords
- Heart Transplant
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnvarsusDrug
Patients will take once daily Envarsus
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rejection and Graft Failure
Evaluate effect on rejection and graft failure by comparing adverse events in standard of care versus experimental groups
Measured: 2 years
Secondary outcomes (1)
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start4 Dec 2017
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Transplant RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shelley Hall, MD, FACC, FHFSA, Principal investigator, Baylor Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373227
- Sponsor's protocol ID
- 017-178
- Acronym
- Veloxis
- Status last verified
- Jan 2023
- First submitted
- 5 Dec 2017
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03373227
- Acronym / sponsor ID
- Veloxis / 017-178
- Keywords
- Heart Transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 14 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective | Experimental | Drug: Envarsus25 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. |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnvarsusPatients will take once daily Envarsus | Drug | Prospective |
Primary outcome
Rejection and Graft Failure
Time frame: 2 years
Evaluate effect on rejection and graft failure by comparing adverse events in standard of care versus experimental groups
1 secondary outcome
Effect of Compliance on Rejection and Graft Failure
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Individual participant dataSharing planned: No
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Magnetic Resonance Elastography as a Method to Estimate Stiffness of Soft Tissues
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shelley Hall, MD, FACC, FHFSA principal investigator
Baylor Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Envarsus in people with Heart Transplant Rejection and Graft Failure, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rejection and Graft Failure (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.