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ClinicalTrials.gov public records Last synced Oct 20, 2026, 11:21 AM EDT

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Showing 1–24 of 42 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Envarsus XR Clear all
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 21, 2024 · Synced Oct 20, 2026, 11:21 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 24, 2019 · Synced Oct 20, 2026, 11:21 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 9, 2023 · Synced Oct 20, 2026, 11:21 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 20, 2026, 11:21 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 20, 2026, 11:21 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 20, 2026, 11:21 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 10, 2023 · Synced Oct 20, 2026, 11:21 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 20, 2026, 11:21 AM EDT
Completed Phase 2 Interventional Results available

Busulfan, Cyclophosphamide, & Antithymocyte Globulin Followed by Stem Cell Transplant in Treating Hematologic Cancer

NCT00611351
View directory record Official record
Conditions
Graft Versus Host Disease, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases, Secondary Myelofibrosis
Interventions
anti-thymocyte globulin, busulfan, cyclophosphamide, mycophenolate mofetil, tacrolimus, polymerase chain reaction, polymorphism analysis, flow cytometry, laboratory biomarker analysis, pharmacogenomic studies, pharmacological study, allogeneic bone marrow transplantation, allogeneic hematopoietic stem cell transplantation, peripheral blood stem cell transplantation
Biological · Drug · Genetic + 2 more
Lead sponsor
University of Nebraska
Other
Eligibility
19 Years to 65 Years
Enrollment
5 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2008
U.S. locations
1
States / cities
Omaha, Nebraska
Source: ClinicalTrials.gov public record
Updated Oct 23, 2023 · Synced Oct 20, 2026, 11:21 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 28, 2026 · Synced Oct 20, 2026, 11:21 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 20, 2026, 11:21 AM EDT
Active, not recruiting Phase 2 Interventional

De-escalated Cyclophosphamide (PTCy) and Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis

NCT05622318
View directory record Official record
Conditions
Graft-versus-host Disease
Interventions
Cyclophosphamide, Tacrolimus, Mycophenolate Mofetil, Ruxolitinib
Drug
Lead sponsor
Medical College of Wisconsin
Other
Eligibility
60 Years and older
Enrollment
56 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
1
States / cities
Milwaukee, Wisconsin
Source: ClinicalTrials.gov public record
Updated Mar 12, 2026 · Synced Oct 20, 2026, 11:21 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 20, 2026, 11:21 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 6, 2018 · Synced Oct 20, 2026, 11:21 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 20, 2026, 11:21 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 20, 2026, 11:21 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 9, 2023 · Synced Oct 20, 2026, 11:21 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 20, 2026, 11:21 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 13, 2020 · Synced Oct 20, 2026, 11:21 AM EDT
Completed Phase 4 Interventional Results available

CNS Study of Patients Switching From Tacrolimus to Envarsus

NCT03270462
View directory record Official record
Conditions
Renal Transplant Patients
Interventions
Envarsus XR
Drug
Lead sponsor
University of Colorado, Denver
Other
Eligibility
18 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2020
U.S. locations
1
States / cities
Aurora, Colorado
Source: ClinicalTrials.gov public record
Updated Jun 2, 2022 · Synced Oct 20, 2026, 11:21 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 8, 2025 · Synced Oct 20, 2026, 11:21 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 20, 2026, 11:21 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 20, 2026, 11:21 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 20, 2026, 11:21 AM EDT