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Showing 1–19 of 19 matching trials from the live ClinicalTrials.gov search.
Local D1 index available.
Filters: Intervention: Immediate-Release Tacrolimus Clear all
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, 2:24 AM 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, 2:24 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 2, 2026, 2:24 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 2, 2026, 2:24 AM EDT
Completed Early Phase 1 Interventional

Assessment of Cognitive Function Before and After Conversion From Immediate Release Tacrolimus to Envarsus XR.

NCT03410654
View directory record Official record
Conditions
Kidney Transplant; Complications
Interventions
Tacrolimus, Extended Release, (Envarsus Xr)
Drug
Lead sponsor
Yale University
Other
Eligibility
18 Years and older
Enrollment
28 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2024
U.S. locations
1
States / cities
New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Aug 20, 2024 · Synced Sep 2, 2026, 2:24 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 2, 2026, 2:24 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 2, 2026, 2:24 AM EDT
Completed Phase 4 Interventional Results available

Effect of Tacrolimus Formulation on Neurological Side Effects in Older Kidney Transplant Recipients

NCT03461445
View directory record Official record
Conditions
Kidney Transplant; Complications, Toxicity, Drug Toxicity, Neurotoxicity
Interventions
Envarsus, IR Tacrolimus
Drug
Lead sponsor
University of California, Davis
Other
Eligibility
60 Years and older
Enrollment
64 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2023
U.S. locations
1
States / cities
Sacramento, California
Source: ClinicalTrials.gov public record
Updated Apr 7, 2025 · Synced Sep 2, 2026, 2:24 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 2, 2026, 2:24 AM 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, 2:24 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 2, 2026, 2:24 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 2, 2026, 2:24 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 2, 2026, 2:24 AM 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, 2:24 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 2, 2026, 2:24 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 2, 2026, 2:24 AM EDT
Completed No phase listed Observational

Alterations in Cognitive Function and Cerebral Blood Flow After Conversion From Immediate Release Tacrolimus to Slow Release Envarsus

NCT03703154
View directory record Official record
Conditions
End Stage Renal Disease
Interventions
Envarsus, Tacrolimus
Drug
Lead sponsor
University of Kansas Medical Center
Other
Eligibility
18 Years to 85 Years
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2021
U.S. locations
1
States / cities
Kansas City, Kansas
Source: ClinicalTrials.gov public record
Updated Apr 26, 2021 · Synced Sep 2, 2026, 2:24 AM 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, 2:24 AM EDT
Completed Phase 4 Interventional Results available

To Compare the Effects of Immediate-release Tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) Formation and the Development of Immune Activation (IA) in de Novo Kidney Transplant Recipients

NCT02723591
View directory record Official record
Conditions
Kidney Transplantation
Interventions
Tacrolimus, Tacrolimus immediate release
Drug
Lead sponsor
Astellas Pharma Global Development, Inc.
Industry
Eligibility
16 Years to 70 Years
Enrollment
599 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2019
U.S. locations
30
States / cities
Birmingham, Alabama • Scottsdale, Arizona • Los Angeles, California + 24 more
Source: ClinicalTrials.gov public record
Updated Dec 17, 2024 · Synced Sep 2, 2026, 2:24 AM EDT