A Phase 2 interventional study of Envarsus in Heart Transplant Rejection, Graft Failure and Compliance, Patient, sponsored by Baylor Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-10-08.
Sponsored by Baylor Research Institute · Phase 2, Interventional, and Treatment
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Among 240 studies in Patient Compliance with a site in United States — 9 open to participants now, 19 under way, 1 of them phase 3. Patient Compliance · United States.
Among the 240 studies in Patient Compliance with a site in United States, this one is the 139th largest by enrollment of the 201 interventional ones that give a count, is one of 19 that started in 2017, is one of 10 in phase 2, and was the 172nd registered.
752 studies on the registry are indexed under Patient Compliance; 72 are open to participants now.
Browse Patient Compliance studies →9 of the 240 studies in Patient Compliance with a site in United States are open now. Recruiting first, the newest first:
VA Office of Research and Development · Sites in United States
Ages 18+ · Healthy volunteers
VA Office of Research and Development · Sites in United States
Ages 18–90
HiDO Technologies · Sites in United States
Ages 65+
University of California, San Francisco · Sites in United States
Ages 60+
University of Georgia · Sites in United States
Ages 18–26 · Women only · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 45 Patient Compliance studies recruiting now, 25 (56%) set no upper age limit and 13 (29%) stop at 75 or younger; 11 take children under 18; 14 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
240 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 14 · Phase 3 12 · Phase 4 10
First in 1993; this study’s year is marked. 19 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 50 is below the median of 116 across 527 interventional studies indexed under Patient Compliance.
Median enrollment 119 across the 201 interventional studies, 92 across the 37 observational. Of the 203 that completed or were terminated, 65 (32%) have results posted.
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23 of 240 have an industry lead sponsor. The 10 most frequent:
Baylor Research Institute is the lead sponsor of 223 studies on the registry; 48 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 9 (39%) have results posted.
Baylor Research Institute has 1 study filed under Patient Compliance — fewer than ten, so there is no comparison to draw.
6 of the studies in Patient Compliance with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07520786University of GeorgiaChanges in 24-hour Activity Cycle Behaviors During a Time-Restricted Eating Intervention in College-Aged Women | 2026-11 |
| NCT04238949Children's Hospital of PhiladelphiaCommunity Health Workers in Pediatric Patients With Newly Diagnosed Type 1 Diabetes | 2027-01 |
| NCT05448560Georgetown UniversityA Multilevel Intervention to Improve Adherence to Childhood Cancer Survivorship | 2027-02-28 |
| NCT05157113University of California, San FranciscoEvaluating a Dropless Postoperative Regimen After Cataract Surgery in a Vulnerable, County-hospital Population | 2027-06-01 |
| NCT06591182BayCare Health SystemEffects of Social Determinants of Health on IV Iron Treatments | 2027-07 |
Add all 6 to your calendar (.ics) → With an account.
Among the 240 studies in Patient Compliance with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Patients will take once daily Envarsus
Rejection and Graft Failure
Evaluate effect on rejection and graft failure by comparing adverse events in standard of care versus experimental groups
Time frame: 2 years
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
Time frame: 2 years
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2017 to primary completion in Dec 2023, 72 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tacrolimus