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Showing 1–19 of 19 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Astagraf XL Clear all
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 6, 2026, 9:23 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 25, 2019 · Synced Sep 6, 2026, 9:23 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 16, 2013 · Synced Sep 6, 2026, 9:23 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 6, 2026, 9:23 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 22, 2023 · Synced Sep 6, 2026, 9:23 AM EDT
Withdrawn Phase 2 Interventional

Autologous Transplant Targeted Against Crohn's

NCT04154735
View directory record Official record
Conditions
Crohn's Disease
Interventions
Fludarabine, Cyclophosphamide, Mesna, Alemtuzumab, G-CSF, Rifaximin, Tacrolimus
Drug
Lead sponsor
Northwestern University
Other
Eligibility
18 Years to 49 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2024
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Nov 7, 2019 · Synced Sep 6, 2026, 9:23 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 18, 2022 · Synced Sep 6, 2026, 9:23 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 6, 2018 · Synced Sep 6, 2026, 9:23 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 11, 2026 · Synced Sep 6, 2026, 9:23 AM EDT
Not listed Phase 4 Interventional

Once-a-day Tacrolimus Conversion Study: The OneTAC Trial

NCT02545972
View directory record Official record
Conditions
Heart Failure
Interventions
tacrolimus extended release
Drug
Lead sponsor
Newark Beth Israel Medical Center
Other
Eligibility
18 Years and older
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2019
U.S. locations
1
States / cities
Newark, New Jersey
Source: ClinicalTrials.gov public record
Updated Sep 20, 2016 · Synced Sep 6, 2026, 9:23 AM EDT
Completed Phase 3 Interventional Results available

Comparative Study of Modified Release (MR) Tacrolimus/Mycophenolate Mofetil (MMF) in de Novo Kidney Transplant Recipients

NCT00064701
View directory record Official record
Conditions
Kidney Transplantation
Interventions
Tacrolimus Modified Release (MR), Tacrolimus, cyclosporine microemulsion, mycophenolate mofetil
Drug
Lead sponsor
Astellas Pharma Inc
Industry
Eligibility
12 Years and older
Enrollment
668 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2009
U.S. locations
48
States / cities
Birmingham, Alabama • Mobile, Alabama • Loma Linda, California + 36 more
Source: ClinicalTrials.gov public record
Updated Dec 4, 2013 · Synced Sep 6, 2026, 9:23 AM EDT
Completed Phase 4 Interventional

Pharmacokinetics of Immunosuppressants in Renal Transplant Candidates Who Have Undergone Laparoscopic Sleeve Gastrectomy

NCT02221583
View directory record Official record
Conditions
End Stage Renal Disease
Interventions
Astagraf XL, Prograf, Mycophenolate mofetil
Drug
Lead sponsor
University of Cincinnati
Other
Eligibility
19 Years to 75 Years
Enrollment
26 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated May 11, 2015 · Synced Sep 6, 2026, 9:23 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 6, 2026, 9:23 AM EDT
Completed Phase 1 Interventional

Nonmyeloablative Hematopoietic Cell Transplantation (HCT) for Patients With Hematologic Malignancies Using Related, HLA-Haploidentical Donors: A Pilot Trial of Peripheral Blood Stem Cells (PBSC) as the Donor Source

NCT02167958
View directory record Official record
Conditions
Leukemia, MDS, Myelofibrosis, Lymphoma
Interventions
Fludarabine, Cyclophosphamide, Mesna, Total Body Irradiation, Hematopoietic stem cell infusion, Tacrolimus, Mycophenolate, G-CSF
Drug · Radiation · Other
Lead sponsor
Rafic Farah, MD
Other
Eligibility
18 Years to 70 Years
Enrollment
28 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2019
U.S. locations
1
States / cities
Pittsburgh, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Oct 14, 2019 · Synced Sep 6, 2026, 9:23 AM EDT
Completed Phase 2 Interventional Results available

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

NCT00282243
View directory record Official record
Conditions
Liver 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
2003 – 2008
U.S. locations
10
States / cities
Palo Alto, California • Denver, Colorado • Baltimore, Maryland + 7 more
Source: ClinicalTrials.gov public record
Updated Sep 29, 2013 · Synced Sep 6, 2026, 9:23 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 6, 2026, 9:23 AM EDT
Completed Phase 2 Interventional Results available

Comparing Cyclophosphamide and Abatacept With Standard of Care Treatment Following Stem Cell Transplantation

NCT03680092
View directory record Official record
Conditions
GVHD, Hematologic Neoplasms
Interventions
Cyclophosphamide, abatacept, Methotrexate, Tacrolimus
Drug
Lead sponsor
Dimitrios Tzachanis, MD PhD
Other
Eligibility
18 Years and older
Enrollment
43 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 Oct 1, 2025 · Synced Sep 6, 2026, 9:23 AM EDT
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 25, 2013 · Synced Sep 6, 2026, 9:23 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 6, 2026, 9:23 AM EDT