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ClinicalTrials.gov public records Last synced Oct 19, 2026, 10:29 AM EDT

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Showing 1–24 of 35 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: tacrolimus extended release Clear all
Completed Phase 2 Interventional Results available

A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Kidney Transplant Patients

NCT00282568
View directory record Official record
Conditions
Kidney Transplantation
Interventions
Tacrolimus Modified Release (MR), tacrolimus
Drug
Lead sponsor
Astellas Pharma Inc
Industry
Eligibility
18 Years to 65 Years
Enrollment
70 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2002 – 2008
U.S. locations
7
States / cities
San Diego, California • Miami, Florida • Minneapolis, Minnesota + 4 more
Source: ClinicalTrials.gov public record
Updated Sep 26, 2013 · Synced Oct 19, 2026, 10:29 AM 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 8, 2026 · Synced Oct 19, 2026, 10:29 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 29, 2024 · Synced Oct 19, 2026, 10:29 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 18, 2024 · Synced Oct 19, 2026, 10:29 AM EDT
Completed No phase listed Observational

Drug Interaction With Envarsus XR and Grapefruit Juice

NCT03916380
View directory record Official record
Conditions
Kidney Transplant; Complications, Drug Interaction Food
Interventions
Grapefruit Juice
Dietary Supplement
Lead sponsor
Shirley M. Tsunoda
Other
Eligibility
18 Years and older
Enrollment
11 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2023
U.S. locations
1
States / cities
La Jolla, California
Source: ClinicalTrials.gov public record
Updated Apr 9, 2025 · Synced Oct 19, 2026, 10:29 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 20, 2023 · Synced Oct 19, 2026, 10:29 AM 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 22, 2024 · Synced Oct 19, 2026, 10:29 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 17, 2026 · Synced Oct 19, 2026, 10:29 AM 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 24, 2020 · Synced Oct 19, 2026, 10:29 AM 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 15, 2021 · Synced Oct 19, 2026, 10:29 AM EDT
Completed Phase 4 Interventional Results available

Trial to Evaluate Safety and Tolerability of Tacrolimus Extended-Release (Astagraf XL) in Human Leukocyte Antigen (HLA) Sensitized Kidney Transplant Recipients

NCT03194321
View directory record Official record
Conditions
End Stage Renal Disease
Interventions
Tacrolimus Extended-Release Oral Capsule
Drug
Lead sponsor
Cedars-Sinai Medical Center
Other
Eligibility
18 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2020
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Jan 19, 2022 · Synced Oct 19, 2026, 10:29 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 17, 2024 · Synced Oct 19, 2026, 10:29 AM 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 27, 2020 · Synced Oct 19, 2026, 10:29 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 13, 2022 · Synced Oct 19, 2026, 10:29 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 2, 2020 · Synced Oct 19, 2026, 10:29 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 11, 2023 · Synced Oct 19, 2026, 10:29 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 8, 2025 · Synced Oct 19, 2026, 10:29 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 27, 2023 · Synced Oct 19, 2026, 10:29 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 22, 2024 · Synced Oct 19, 2026, 10:29 AM 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 15, 2026 · Synced Oct 19, 2026, 10:29 AM EDT
Completed Phase 2 Interventional Results available

A Study of a Modified-Release Tacrolimus Based Immunosuppression Regimen in Stable Pediatric Liver Transplant Patients

NCT00282256
View directory record Official record
Conditions
Liver Transplantation
Interventions
tacrolimus modified release (MR), tacrolimus
Drug
Lead sponsor
Astellas Pharma Inc
Industry
Eligibility
Up to 12 Years
Enrollment
19 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004 – 2008
U.S. locations
5
States / cities
Atlanta, Georgia • Indianapolis, Indiana • New Orleans, Louisiana + 2 more
Source: ClinicalTrials.gov public record
Updated Oct 17, 2013 · Synced Oct 19, 2026, 10:29 AM 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 26, 2019 · Synced Oct 19, 2026, 10:29 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 10, 2025 · Synced Oct 19, 2026, 10:29 AM 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 7, 2018 · Synced Oct 19, 2026, 10:29 AM EDT