Tacrolimus

Generic Name: Tacrolimus

Brand Names: Advagraf, Astagraf, Envarsus, Modigraf, Prograf, Protopic, Tacforius

Drug Type: Small Molecule

Chemical Formula: C_₄₄H_₆₉NO_₁₂

CAS Number: 104987-11-3

Unique Ingredient Identifier: Y5L2157C4J

Background: Tacrolimus (also FK-506 or Fujimycin) is an immunosuppressive drug whose main use is after organ transplant to reduce the activity of the patient's immune system and so the risk of organ rejection. It is also used in a topical preparation in the treatment of severe atopic dermatitis, severe refractory uveitis after bone marrow transplants, and the skin condi...

Indication: Immediate-release formulations of tacrolimus are indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, heart, or lung transplants, in combination with other immunosuppressants. Extended-release formulations of tacrolimus are indicated for the prophylaxis of organ rejection in adult and pediatric ...

Associated Conditions: Graft-versus-host Disease (GVHD), Heart Transplant Rejection, Kidney Transplant Rejection, Liver Transplant Rejection, Lung Transplant Rejection, Oral Lichen Planus, Psoriasis, Pyoderma Gangrenosum, Rheumatoid Arthritis, Severe Atopic Dermatitis, Vitiligo, Moderate Atopic dermatitis

Associated Therapies: -

Clinical Trials

The Vienna Prograf and Endothelial Progenitor Cell Extension Study

Phase 4

Completed

Conditions: Renal Failure
Immunosuppression

Interventions: Drug: Tacrolimus

First Posted Date: 2018-11-23

Last Posted Date: 2018-11-23

Lead Sponsor: Medical University of Vienna

Target Recruit Count: 87

Registration Number: NCT03751332

A Study Comparing Biologics + Methotrexate With Biologics + Tacrolimus in Patients With Rheumatoid Arthritis (RA)

Phase 4

Completed

Conditions: Rheumatoid Arthritis (RA)

Interventions: Drug: methotrexate
Drug: tacrolimus
Biological: adalimumab
Biological: tocilizumab
Biological: abatacept

First Posted Date: 2018-11-09

Last Posted Date: 2024-10-31

Lead Sponsor: Astellas Pharma Korea, Inc.

Target Recruit Count: 21

Registration Number: NCT03737708

Locations: 🇰🇷
Site KR82003, Daegu, Korea, Republic of
🇰🇷
Site KR82007, Daegu, Korea, Republic of
🇰🇷
Site KR82002, Incheon, Korea, Republic of

and more 7 locations

Total Body Irradiation +/- Total Lymphoid Irradiation & Anti-Thymocyte Globulin in Non-myeloablative Hematopoietic Cell Transplantation

Phase 2

Completed

Conditions: Myelodysplastic Syndromes
Chronic Lymphocytic Leukemia
T-cell Lymphoma
Acute Myeloid Leukemia
B-cell Lymphoma
Hodgkin Lymphoma
Chronic Myelomonocytic Leukemia
Myeloproliferative Disorder
Non Hodgkin Lymphoma

Interventions: Radiation: Total body irradiation (TBI)
Drug: Anti-thymocyte globulin (ATG)
Drug: Tacrolimus
Drug: Mycophenolate mofetil (MMF)
Radiation: Total lymphoid irradiation (TLI)

First Posted Date: 2018-11-08

Last Posted Date: 2023-12-12

Lead Sponsor: Stanford University

Target Recruit Count: 22

Registration Number: NCT03734601

Locations: 🇺🇸
Stanford University School of Medicine, Stanford, California, United States

2-Step Approach to Stem Cell Transplant in Treating Participants With Hematological Malignancies

Phase 2

Active, not recruiting

Conditions: Hematopoietic and Lymphoid Cell Neoplasm

Interventions: Radiation: Total-Body Irradiation
Procedure: Donor Lymphocyte Infusion
Drug: Cyclophosphamide
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Drug: Tacrolimus
Drug: Mycophenolate Mofetil

First Posted Date: 2018-10-19

Last Posted Date: 2024-03-05

Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Target Recruit Count: 10

Registration Number: NCT03712878

Locations: 🇺🇸
Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania, United States

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

Completed

Conditions: End Stage Renal Disease

Interventions: Drug: Envarsus
Drug: Tacrolimus

First Posted Date: 2018-10-11

Last Posted Date: 2021-04-27

Lead Sponsor: University of Kansas Medical Center

Target Recruit Count: 30

Registration Number: NCT03703154

Locations: 🇺🇸
University of Kansas Medical Center, Kansas City, Kansas, United States

PROACTIVE: Preventing Acute/Chronic GVHD With TocIlizumab Combined With GVHD Prophylaxis Post allogEneic Transplant

Phase 2

Completed

Conditions: Hematologic Malignancy

Interventions: Drug: Tacrolimus
Drug: Methotrexate
Drug: Tocilizumab

First Posted Date: 2018-10-09

Last Posted Date: 2023-04-19

Lead Sponsor: Medical College of Wisconsin

Target Recruit Count: 29

Registration Number: NCT03699631

Locations: 🇺🇸
Froedtert Hospital, Milwaukee, Wisconsin, United States

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

Phase 2

Active, not recruiting

Conditions: GVHD
Hematologic Neoplasms

Interventions: Drug: Cyclophosphamide
Drug: Methotrexate
Drug: abatacept
Drug: Tacrolimus

First Posted Date: 2018-09-21

Last Posted Date: 2024-10-02

Lead Sponsor: Dimitrios Tzachanis, MD PhD

Target Recruit Count: 43

Registration Number: NCT03680092

Locations: 🇺🇸
UC San Diego Moores Cancer Center, La Jolla, California, United States

211At-BC8-B10 Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory High-Risk Acute Leukemia or Myelodysplastic Syndrome

Phase 1

Suspended

Conditions: Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Recurrent Acute Lymphoblastic Leukemia
Refractory Acute Myeloid Leukemia
Refractory Mixed Phenotype Acute Leukemia
Acute Myeloid Leukemia in Remission
Recurrent Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia in Remission
Myelodysplastic Syndrome With Excess Blasts
Chronic Myelomonocytic Leukemia
Refractory Acute Lymphoblastic Leukemia

Interventions: Biological: Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10
Drug: Cyclophosphamide
Radiation: Total-Body Irradiation
Procedure: Peripheral Blood Stem Cell Transplantation
Procedure: Bone Marrow Transplantation
Drug: Mycophenolate Mofetil
Biological: Recombinant Granulocyte Colony-Stimulating Factor
Drug: Fludarabine Phosphate
Drug: Tacrolimus
Procedure: Bone Marrow Aspiration and Biopsy
Procedure: Biospecimen Collection

First Posted Date: 2018-09-14

Last Posted Date: 2024-05-10

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 30

Registration Number: NCT03670966

Locations: 🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

Glucose Disorders Induced by Tacrolimus on Pre Transplantation Endstage Renal Disease Patients

Phase 4

Recruiting

Conditions: Kidney Failure, Chronic

Interventions: Drug: Tacrolimus

First Posted Date: 2018-08-21

Last Posted Date: 2024-07-16

Lead Sponsor: Centre Hospitalier Departemental Vendee

Target Recruit Count: 30

Registration Number: NCT03640026

Locations: 🇫🇷
Centre Hospitalier Universitaire Nantes, Nantes, France
🇫🇷
Centre Hospitalier Départemental Vendée, La Roche-sur-Yon, France

CD40-L Blockade for Prevention of Acute Graft-Versus-Host Disease

Phase 1

Completed

Conditions: GVHD, Acute
Graft-versus-host-disease
GVHD

Interventions: Drug: BMS-986004
Drug: Sirolimus
Drug: Tacrolimus

First Posted Date: 2018-07-30

Last Posted Date: 2024-11-27

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 45

Registration Number: NCT03605927

Locations: 🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
🇺🇸
City of Hope Cancer Center, Duarte, California, United States
🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

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