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ClinicalTrials.gov public records Last synced Sep 2, 2026, 5:39 PM EDT

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Showing 1–24 of 35 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Extended-release tacrolimus Clear all
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 2, 2026, 5:39 PM 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 2, 2026, 5:39 PM EDT
Enrolling by invitation Phase 1 Interventional

Islet Transplantation With Recipient T-Reg Cells or Deceased Donor Vertebral Bone Marrow Therapy

NCT05973734
View directory record Official record
Conditions
Islet Transplantation
Interventions
Infusion of recipient T regulatory cell, Infusion of concomitant Donor Derived Vertebral Bone Marrow
Biological
Lead sponsor
Stanford University
Other
Eligibility
18 Years to 70 Years
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2030
U.S. locations
1
States / cities
Palo Alto, California
Source: ClinicalTrials.gov public record
Updated Jun 7, 2026 · Synced Sep 2, 2026, 5:39 PM EDT
Completed Phase 2 Interventional Results available

Envarsus XR in Lung Transplant

NCT04420195
View directory record Official record
Conditions
Lung Transplant
Interventions
Extended-Release Tacrolimus, Immediate-Release Tacrolimus
Drug
Lead sponsor
NYU Langone Health
Other
Eligibility
18 Years to 75 Years
Enrollment
41 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2022
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Jan 21, 2024 · Synced Sep 2, 2026, 5:39 PM EDT
Recruiting Early Phase 1 Interventional

Early Use of Long-acting Tacrolimus in Lung Transplant Recipients

NCT04469842
View directory record Official record
Conditions
Lung Transplant; Complications
Interventions
Tacrolimus Extended Release Oral Tablet [Envarsus], Tacrolimus, Mycophenolate Mofetil Hydrochloride, Prednisone, Azathioprine
Drug
Lead sponsor
Vanderbilt University Medical Center
Other
Eligibility
18 Years and older
Enrollment
48 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2027
U.S. locations
1
States / cities
Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated May 14, 2026 · Synced Sep 2, 2026, 5:39 PM EDT
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 2, 2026, 5:39 PM 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 2, 2026, 5:39 PM 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 2, 2026, 5:39 PM 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 2, 2026, 5:39 PM EDT
Completed Phase 4 Interventional Results available

Envarsus in Delayed Graft Function (E-DGF)

NCT03864926
View directory record Official record
Conditions
Delayed Graft Function
Interventions
Envarsus XR, Tacrolimus
Drug
Lead sponsor
University of Wisconsin, Madison
Other
Eligibility
18 Years and older
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
1
States / cities
Madison, Wisconsin
Source: ClinicalTrials.gov public record
Updated Jul 19, 2023 · Synced Sep 2, 2026, 5:39 PM 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 2, 2026, 5:39 PM 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 2, 2026, 5:39 PM 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 2, 2026, 5:39 PM EDT
Completed Phase 1Phase 2 Interventional Results available

Comparison of the Cognitive and Motor Effects of Treatment Between an Immediate- and Extended-release Tacrolimus (Envarsus® XR) Based Immunosuppression Regimen in Kidney Transplant Recipients

NCT03437577
View directory record Official record
Conditions
Kidney Transplant Failure and Rejection
Interventions
immediate-release tacrolimus, extended release tacrolimus
Drug
Lead sponsor
University of Minnesota
Other
Eligibility
18 Years to 65 Years
Enrollment
18 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
1
States / cities
Minneapolis, Minnesota
Source: ClinicalTrials.gov public record
Updated Apr 14, 2021 · Synced Sep 2, 2026, 5:39 PM EDT
Completed Phase 4 Interventional Results available

A Pharmacokinetic Analysis of Tacrolimus ER Dosing in Obese Kidney Transplant Recipients

NCT02444143
View directory record Official record
Conditions
Kidney Transplantation
Interventions
tacrolimus extended release
Drug
Lead sponsor
University of Illinois at Chicago
Other
Eligibility
18 Years to 100 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2017
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Nov 6, 2018 · Synced Sep 2, 2026, 5:39 PM 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 2, 2026, 5:39 PM 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 2, 2026, 5:39 PM 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 2, 2026, 5:39 PM 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 2, 2026, 5:39 PM EDT
Not listed Phase 4 Interventional

Renal Tubular Injury and Transplant Outcomes in Cardiac Recipients Converting From IR Tacrolimus to XR Tacrolimus

NCT04917718
View directory record Official record
Conditions
Chronic Kidney Diseases, Heart Transplant
Interventions
Conversion from IR Tacrolimus to XR Tacrolimus
Drug
Lead sponsor
Loyola University
Other
Eligibility
18 Years to 80 Years
Enrollment
42 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
1
States / cities
Maywood, Illinois
Source: ClinicalTrials.gov public record
Updated Apr 12, 2022 · Synced Sep 2, 2026, 5:39 PM EDT
Terminated Not applicable Interventional Results available

Envarsus XR in African American Renal Transplant Recipients

NCT02956005
View directory record Official record
Conditions
Renal Transplant Recipients
Interventions
ENVARSUS®
Drug
Lead sponsor
Georgetown University
Other
Eligibility
18 Years to 80 Years
Enrollment
18 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2018
U.S. locations
1
States / cities
Washington D.C., District of Columbia
Source: ClinicalTrials.gov public record
Updated Mar 23, 2020 · Synced Sep 2, 2026, 5:39 PM EDT
Completed Phase 3 Interventional Results available

Study to Ascertain if Prolonged Release Tacrolimus (FK506E - MR4) is Safe and Effective When Used in the Long Term and in Combination With Other Immunosuppressive Drugs in Patients Who Have Received a Transplant

NCT02118896
View directory record Official record
Conditions
Heart Transplantation, Liver Transplantation, Kidney Transplantation
Interventions
FK506E
Drug
Lead sponsor
Astellas Pharma Europe Ltd.
Industry
Eligibility
18 Years and older
Enrollment
850 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2009
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Nov 21, 2024 · Synced Sep 2, 2026, 5:39 PM EDT
Completed Phase 4 Interventional Results available

Dosing Requirements of Astagraf XL® in African American Kidney Transplant Recipients

NCT02953873
View directory record Official record
Conditions
Immunosuppression
Interventions
Tacrolimus Extended Release Capsule, Mycophenolate mofetil, Prednisone, Mycophenolate Sodium
Drug
Lead sponsor
Medical University of South Carolina
Other
Eligibility
18 Years and older
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2018
U.S. locations
1
States / cities
Charleston, South Carolina
Source: ClinicalTrials.gov public record
Updated Dec 25, 2019 · Synced Sep 2, 2026, 5:39 PM EDT
Completed Phase 4 Interventional Results available

Comparison of Tacrolimus Extended-Release (Envarsus XR) to Tacrolimus Immediate-Release in Human Leukocyte Antigen (HLA) Sensitized Kidney Transplant Recipients

NCT04225988
View directory record Official record
Conditions
Kidney Transplant Rejection
Interventions
Extended-release tacrolimus, Immediate-release tacrolimus
Drug
Lead sponsor
Cedars-Sinai Medical Center
Other
Eligibility
18 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Jul 9, 2024 · Synced Sep 2, 2026, 5:39 PM EDT