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Showing 1–24 of 24 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Once-daily envarsus XR Clear all
Terminated Early Phase 1 Interventional

Pilot Study of Treatment for Subclinical AMR (Antibody-mediated Rejection) in Kidney Transplant Recipients

NCT03380936
View directory record Official record
Conditions
Kidney Transplant Rejection
Interventions
Tacrolimus Extended Release Oral Tablet [Envarsus], Plasma Exchange and IVIG (Intravenous Immunoglobulin )
Drug · Other
Lead sponsor
University of Colorado, Denver
Other
Eligibility
18 Years to 79 Years
Enrollment
4 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2019
U.S. locations
1
States / cities
Aurora, Colorado
Source: ClinicalTrials.gov public record
Updated Oct 26, 2020 · Synced Sep 17, 2026, 2:31 AM EDT
Recruiting Phase 4 Interventional

Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant Recipients

NCT06751992
View directory record Official record
Conditions
Kidney Transplant Recipients, Old Age
Interventions
Conversion to extended-release tacrolimus, Maintenance of immediate-release tacrolimus
Drug
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
65 Years and older
Enrollment
92 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2027
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated May 27, 2026 · Synced Sep 17, 2026, 2:31 AM EDT
Completed Phase 3 Interventional Results available

Pharmacokinetic Comparison Of All FK-506 Formulations

NCT02339246
View directory record Official record
Conditions
Renal Failure
Interventions
Prograf vs Envarsus XR vs Astagraf XL, Prograf vs Astagraf XL vs Envarsus XR
Drug
Lead sponsor
Veloxis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
32 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Jan 17, 2016 · Synced Sep 17, 2026, 2:31 AM EDT
Completed Phase 4 Interventional Accepts healthy volunteers

Evaluation Dose Adjustments in Kidney Transplant Patients on Immediate Release and Extended Release Tacrolimus

NCT03760263
View directory record Official record
Conditions
Transplant;Failure,Kidney
Interventions
Tacrolimus
Drug
Lead sponsor
Sentara Norfolk General Hospital
Other
Eligibility
18 Years to 70 Years
Enrollment
46 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2023
U.S. locations
1
States / cities
Norfolk, Virginia
Source: ClinicalTrials.gov public record
Updated Feb 28, 2024 · Synced Sep 17, 2026, 2:31 AM EDT
Completed Phase 4 Interventional Results available

Envarsus XR Compared to Immediate Release Tacrolimus

NCT03979365
View directory record Official record
Conditions
Kidney Transplant Recipients
Interventions
Envarsus XR, Tacrolimus twice daily
Drug
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years and older
Enrollment
261 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
3
States / cities
Phoenix, Arizona • Jacksonville, Florida • Rochester, Minnesota
Source: ClinicalTrials.gov public record
Updated Dec 17, 2025 · Synced Sep 17, 2026, 2:31 AM EDT
Completed Phase 3 Interventional Results available

Crossover Study to Compare PK of Once Daily LCP-Tacro Tablets to Generic Tacrolimus Capsules Twice Daily.

NCT01962922
View directory record Official record
Conditions
Renal Failure
Interventions
LCP-Tacro, Tacrolimus -IR
Drug
Lead sponsor
Veloxis Pharmaceuticals
Industry
Eligibility
18 Years to 70 Years
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
3
States / cities
Chicago, Illinois • St Louis, Missouri • Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Jun 5, 2018 · Synced Sep 17, 2026, 2:31 AM EDT
Completed No phase listed Observational

Converting Elderly Kidney Transplant Recipients From Tacrolimus to Envarsus to Limit Neurological AE and Improve QOL

NCT03263052
View directory record Official record
Conditions
Disorder Related to Renal Transplantation
Interventions
Tacrolimus XR (Envarsus)
Drug
Lead sponsor
University of Illinois at Chicago
Other
Eligibility
60 Years and older
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2020
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Apr 21, 2020 · Synced Sep 17, 2026, 2:31 AM EDT
Terminated Phase 4 Interventional Results available

Once Daily Immunosuppression Regimen

NCT03555448
View directory record Official record
Conditions
Kidney Transplant; Complications
Interventions
Once daily immunosuppression regimen, Twice daily immunosuppression regimen
Drug
Lead sponsor
Washington University School of Medicine
Other
Eligibility
18 Years and older
Enrollment
51 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2023
U.S. locations
1
States / cities
St Louis, Missouri
Source: ClinicalTrials.gov public record
Updated Jan 21, 2025 · Synced Sep 17, 2026, 2:31 AM EDT
Completed Phase 4 Interventional Results available

Cognitive Outcomes in Stable Renal Transplant Patients Switched fromTacrolimus to Envarsus XR™

NCT04838288
View directory record Official record
Conditions
Renal Transplant
Interventions
Change from Prograf to Envarsus XR
Drug
Lead sponsor
Vanderbilt University Medical Center
Other
Eligibility
18 Years to 70 Years
Enrollment
56 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2025
U.S. locations
1
States / cities
Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated Apr 28, 2026 · Synced Sep 17, 2026, 2:31 AM EDT
Terminated Phase 4 Interventional

Simplified IMmunosuppressive Protocol Utilizing Low Dose EnvarsusXR

NCT04773392
View directory record Official record
Conditions
Kidney Transplantation, Kidney Transplant Rejection
Interventions
Twice-daily Tacrolimus, Once-daily envarsus XR, Induction Immunosuppression with Basiliximab or Rabbit Anti Thymoglobulin (rATG), Methylprednisolone, prednisone, Mycophenolate mofetil (MMF) or Mycophenolic acid (MPA), Azathioprine
Drug
Lead sponsor
University of Southern California
Other
Eligibility
18 Years to 85 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Nov 9, 2025 · Synced Sep 17, 2026, 2:31 AM EDT
Completed Not applicable Interventional Results available

Once-daily Regimen With Envarsus® to Optimize Immunosuppression Management and Outcomes in Kidney Transplant Recipients

NCT02954198
View directory record Official record
Conditions
Immunosuppression
Interventions
Tacrolimus, Prednisone, Mycophenolate mofetil, Everolimus
Drug
Lead sponsor
Medical University of South Carolina
Other
Eligibility
18 Years and older
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2018
U.S. locations
1
States / cities
Charleston, South Carolina
Source: ClinicalTrials.gov public record
Updated Dec 23, 2019 · Synced Sep 17, 2026, 2:31 AM EDT
Active, not recruiting Phase 4 Interventional

Pulse Wave Velocity, Tacrolimus Time in Therapeutic Range and CV in African American Kidney Transplants

NCT03841097
View directory record Official record
Conditions
Kidney Transplant; Complications
Interventions
Extended Release Tacrolimus Tablets, Immediate Release Tacrolimus Capsule
Drug
Lead sponsor
Roy D. Bloom, MD
Other
Eligibility
18 Years to 75 Years
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2026
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Jul 16, 2026 · Synced Sep 17, 2026, 2:31 AM EDT
Active, not recruiting Phase 4 Interventional

Envarsus XR® in Adolescent Renal Transplant Recipients

NCT03266393
View directory record Official record
Conditions
Kidney Transplantation, Renal Transplantation, Grafting, Kidney
Interventions
Envarsus XR, Tacrolimus
Drug
Lead sponsor
University of California, Los Angeles
Other
Eligibility
13 Years to 20 Years
Enrollment
28 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2023
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Feb 8, 2023 · Synced Sep 17, 2026, 2:31 AM EDT
Terminated Early Phase 1 Interventional

Immunosuppressant Medication Dosed Daily After Kidney Transplant

NCT04156204
View directory record Official record
Conditions
Kidney Transplant Rejection, Medication Adherence
Interventions
Medication Event Monitoring System (MEMS), Once-Daily Tacrolimus extended release
Other · Drug
Lead sponsor
University of Colorado, Denver
Other
Eligibility
13 Years to 22 Years
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
1
States / cities
Aurora, Colorado
Source: ClinicalTrials.gov public record
Updated Dec 1, 2020 · Synced Sep 17, 2026, 2:31 AM EDT
Not listed Phase 1 Interventional

Prospective Pilot Feasibility Study Comparing Envarsus Once-a-day to Tacrolimus Twice-a-day Immunosuppressive Regimen on Drug Bioavailability in Hispanic First Time Kidney Transplant Recipients

NCT03438773
View directory record Official record
Conditions
Kidney Transplant; Complications, Kidney Transplant Failure and Rejection
Interventions
Envarsus, Tacrolimus
Drug
Lead sponsor
California Institute of Renal Research
Other
Eligibility
18 Years and older
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2023
U.S. locations
1
States / cities
San Diego, California
Source: ClinicalTrials.gov public record
Updated Feb 8, 2023 · Synced Sep 17, 2026, 2:31 AM EDT
Not listed Phase 4 Interventional

Veloxis de Novo Kidney Transplant ECSWD

NCT03828682
View directory record Official record
Conditions
Kidney Transplantation, Immunosuppression
Interventions
Tacrolimus Extended Release Oral Tablet [Envarsus], Mycophenolate Mofetil, Mycophenolic Acid Oral Product, Tacrolimus, Methylprednisolone, Prednisone, Rabbit Anti-Human T-Lymphocyte Globulin Injectable Solution [Thymoglobulin]
Drug
Lead sponsor
Simon Tremblay, PharmD, PhD
Other
Eligibility
18 Years and older
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
2
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated May 12, 2020 · Synced Sep 17, 2026, 2:31 AM EDT
Completed Phase 2 Interventional

Envarsus XL Immunosuppression Following Liver Transplantation

NCT03828058
View directory record Official record
Conditions
Recipients of Liver Transplant
Interventions
Envarsus XR, Prograf
Drug
Lead sponsor
Methodist Healthcare - Memphis
Other
Eligibility
18 Years and older
Enrollment
110 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
1
States / cities
Memphis, Tennessee
Source: ClinicalTrials.gov public record
Updated Jan 11, 2021 · Synced Sep 17, 2026, 2:31 AM EDT
Completed Phase 4 Interventional Results available

Envarsus Neurotoxicity Burden in Liver Transplant Patients

NCT03823768
View directory record Official record
Conditions
Neurotoxicity, Liver Transplant; Complications
Interventions
Envarsus, Tacrolimus Immediate release
Drug
Lead sponsor
Medical University of South Carolina
Other
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2024
U.S. locations
1
States / cities
Charleston, South Carolina
Source: ClinicalTrials.gov public record
Updated Mar 29, 2025 · Synced Sep 17, 2026, 2:31 AM EDT
Recruiting Phase 2Phase 3 Interventional

CIRTEN-Simultaneous Pancreas-Kidney Transplant Recipients

NCT03769298
View directory record Official record
Conditions
Kidney Pancreas Transplantation
Interventions
Envarsus XR
Drug
Lead sponsor
University of Wisconsin, Madison
Other
Eligibility
18 Years to 70 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2026
U.S. locations
1
States / cities
Madison, Wisconsin
Source: ClinicalTrials.gov public record
Updated Apr 12, 2026 · Synced Sep 17, 2026, 2:31 AM EDT
Completed Phase 2 Interventional Results available

Conversion to Envarsus Post Kidney Transplant Protects Against BK Infection

NCT03762473
View directory record Official record
Conditions
Renal Transplant Infection
Interventions
Study Group, Control Group
Drug
Lead sponsor
University of Alabama at Birmingham
Other
Eligibility
18 Years to 99 Years
Enrollment
89 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
1
States / cities
Birmingham, Alabama
Source: ClinicalTrials.gov public record
Updated Jul 26, 2023 · Synced Sep 17, 2026, 2:31 AM EDT
Completed Phase 4 Interventional Results available

Dosing Strategies for de Novo Once-daily Extended Release Tacrolimus (LCPT) in Kidney Transplant Recipients

NCT03713645
View directory record Official record
Conditions
Kidney Transplant
Interventions
Tacrolimus Extended Release Oral Tablet [Envarsus] 0.13mg/kg/day initiated within post-operative day 3 after kidney transplant
Drug
Lead sponsor
Temple University
Other
Eligibility
18 Years and older
Enrollment
36 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2022
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated May 10, 2023 · Synced Sep 17, 2026, 2:31 AM EDT
Completed Phase 3 Interventional Results available

Extended Release Tacrolimus vs. Twice-Daily Tacrolimus

NCT03289650
View directory record Official record
Conditions
End Stage Renal Disease, Rejection of Renal Transplant
Interventions
Tacrolimus, Tacrolimus Extended Release Oral Tablet [Envarsus]
Drug
Lead sponsor
Lorenzo Gallon
Other
Eligibility
18 Years to 65 Years
Enrollment
29 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2021
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Apr 9, 2023 · Synced Sep 17, 2026, 2:31 AM EDT
Completed Phase 4 Interventional Results available

Envarsus on the Effect of Total Tacrolimus Dose/Trough Level Ratio on Renal Function (eGFR) in Kidney Transplantation

NCT03511560
View directory record Official record
Conditions
Renal Transplant Rejection, Kidney Transplant Failure and Rejection
Interventions
Tacrolimus Extended Release Oral Tablet, Tacrolimus
Drug
Lead sponsor
Columbia University
Other
Eligibility
18 Years to 80 Years
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2021
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Jul 16, 2024 · Synced Sep 17, 2026, 2:31 AM EDT
Completed Phase 2 Interventional

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

NCT03373227
View directory record Official record
Conditions
Heart Transplant Rejection, Graft Failure, Compliance, Patient
Interventions
Envarsus
Drug
Lead sponsor
Baylor Research Institute
Other
Eligibility
18 Years to 80 Years
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2023
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Oct 7, 2025 · Synced Sep 17, 2026, 2:31 AM EDT