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

Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy

Not Applicable

Conditions: Clinical Trial
Idiopathic Membranous Nephropathy
Tacrolimus

Interventions: Drug: Tacrolimus
Drug: Prednisone

First Posted Date: 2019-03-06

Last Posted Date: 2019-06-25

Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Target Recruit Count: 124

Registration Number: NCT03864250

Locations: 🇨🇳
Shanghai Xinhua Hospital affliated to Shanghai Jiao Tong University, School of Medicine, Shanghai, China

Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Leukemia or Lymphoma Undergoing Stem Cell Transplantation

Phase 2

Recruiting

Conditions: Acute Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia
Lymphocytic Neoplasm
Lymphoma

Interventions: Procedure: Allogeneic Bone Marrow Transplantation
Biological: Filgrastim-sndz
Drug: Bendamustine
Drug: Fludarabine
Drug: Melphalan
Biological: Inotuzumab Ozogamicin
Procedure: Peripheral Blood Stem Cell Transplantation
Biological: Rituximab
Drug: Tacrolimus

First Posted Date: 2019-02-27

Last Posted Date: 2024-12-10

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 44

Registration Number: NCT03856216

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Veloxis de Novo Kidney Transplant ECSWD

Phase 4

Conditions: Kidney Transplantation
Immunosuppression

Interventions: Drug: Tacrolimus Extended Release Oral Tablet [Envarsus]
Drug: Mycophenolate Mofetil
Drug: Mycophenolic Acid Oral Product
Drug: Tacrolimus
Drug: Methylprednisolone
Drug: Prednisone
Drug: Rabbit Anti-Human T-Lymphocyte Globulin Injectable Solution [Thymoglobulin]

First Posted Date: 2019-02-04

Last Posted Date: 2020-05-13

Lead Sponsor: Simon Tremblay, PharmD, PhD

Target Recruit Count: 60

Registration Number: NCT03828682

Locations: 🇺🇸
University of Cincinnati, Cincinnati, Ohio, United States
🇺🇸
The Christ Hospital, Cincinnati, Ohio, United States

Envarsus XL Immunosuppression Following Liver Transplantation

Phase 2

Completed

Conditions: Recipients of Liver Transplant

Interventions: Drug: Envarsus XR
Drug: Prograf

First Posted Date: 2019-02-04

Last Posted Date: 2021-01-12

Lead Sponsor: Methodist Healthcare

Target Recruit Count: 110

Registration Number: NCT03828058

Locations: 🇺🇸
Methodist Healthcare, University Hospital, Memphis, Tennessee, United States

Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients With Selected Unresectable or Metastatic Cancers

Phase 1

Active, not recruiting

Conditions: Pathologic Stage IV Cutaneous Melanoma AJCC v8
Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8
Metastatic Basal Cell Carcinoma
Metastatic Merkel Cell Carcinoma
Metastatic Skin Squamous Cell Carcinoma
Pathologic Stage III Cutaneous Melanoma AJCC v8
Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
Pathologic Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8
Unresectable Merkel Cell Carcinoma
Metastatic Melanoma

Interventions: Biological: Ipilimumab
Biological: Nivolumab
Drug: Prednisone
Drug: Tacrolimus

First Posted Date: 2019-01-25

Last Posted Date: 2024-10-17

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 12

Registration Number: NCT03816332

Locations: 🇺🇸
Northwestern University, Chicago, Illinois, United States
🇺🇸
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States

and more 4 locations

Impact of Lymphocyte Anti-metabolite Immunosuppressions on Donor-Specific Anti-HLA Antibody and Kidney Graft Outcome

Phase 4

Completed

Conditions: Kidney Transplant

Interventions: Drug: Mycophenolate mofetil 500mg Tab. or 250mg Cap.
Drug: Tacrolimus
Drug: Methylprednisolone/prednisolone
Drug: Basiliximab

First Posted Date: 2019-01-07

Last Posted Date: 2024-05-22

Lead Sponsor: Chong Kun Dang Pharmaceutical

Target Recruit Count: 169

Registration Number: NCT03794492

Locations: 🇰🇷
Ajou University Hospital, Suwan, Korea, Republic of

Multicenter Registry of Pediatric Lupus Nephritis in China

Recruiting

Conditions: Lupus Nephritis
Children
Steroid
Immunosuppressive Treatment

Interventions: Drug: Corticosteroid
Drug: Rituximab
Drug: Hydroxychloroquine
Drug: Mycophenolate Mofetil
Drug: Cyclophosphamide
Drug: Cyclosporine A
Drug: Azathioprine
Drug: Tacrolimus

First Posted Date: 2019-01-03

Last Posted Date: 2019-04-05

Lead Sponsor: Xiqiang Dang

Target Recruit Count: 1200

Registration Number: NCT03791827

Locations: 🇨🇳
The Second Xiangya Hospital, Central South University, Changsha, Hunan, China

Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant

First Posted Date: 2018-12-19

Last Posted Date: 2024-11-14

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 68

Registration Number: NCT03779854

Locations: 🇺🇸
Children's Hospital of Los Angeles, Los Angeles, California, United States
🇺🇸
Children's National Medical Center, Washington, District of Columbia, United States
🇺🇸
Children's Healthcare of Atlanta, Atlanta, Georgia, United States

and more 7 locations

Cyclophosphamide and Azathioprine vs Tacrolimus in Antisynthetase Syndrome-related Interstitial Lung Disease

Phase 3

Conditions: Interstitial Lung Disease
Antisynthetase Syndrome (ASS)

Interventions: Drug: Cyclophosphamide and azathioprine
Drug: Tacrolimus

First Posted Date: 2018-12-10

Last Posted Date: 2021-02-09

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 76

Registration Number: NCT03770663

Locations: 🇫🇷
Hôpital Universitaire Pitié Salpêtrière, Paris, France

Evaluation Dose Adjustments in Kidney Transplant Patients on Immediate Release and Extended Release Tacrolimus

Phase 4

Completed

Conditions: Transplant;Failure,Kidney

Interventions: Drug: Tacrolimus

First Posted Date: 2018-11-30

Last Posted Date: 2024-02-29

Lead Sponsor: Sentara Norfolk General Hospital

Target Recruit Count: 46

Registration Number: NCT03760263

Locations: 🇺🇸
Sentara Norfolk General Hospital, Norfolk, Virginia, United States

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