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Last Updated: June 6, 2020

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CLINICAL TRIALS PROFILE FOR PROGRAF

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505(b)(2) Clinical Trials for Prograf

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT00717470 A Study in Kidney Transplant Subjects to Investigate the Optimal Suppression of Immunity to Help Prevent Kidney Rejection Completed Astellas Pharma Inc Phase 4 2008-05-01 To compare how well the new formulation of Tacrolimus® used once daily, in combination with other drugs helps prevent the rejection of a new kidney after transplantation compared to the twice daily dose of Tacrolimus
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Prograf

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00034528 Stem Cell Transplantation After Reduced-Dose Chemotherapy for Patients With Sickle Cell Disease or Thalassemia Terminated National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 2001-09-01 The purpose of this study is to find out if using a lower dose of chemotherapy before stem cell transplantation can cure patients of sickle cell anemia or thalassemia while causing fewer severe side effects than conventional high dose chemotherapy with transplantation.
NCT00036153 Study to Assess Efficacy of Tacrolimus + Methotrexate Versus Placebo + Methotrexate in Treatment of Rheumatoid Arthritis Completed Astellas Pharma US, Inc. Phase 3 2002-03-01 The purpose of this study is to evaluate the efficacy of the combination of tacrolimus + methotrexate compared to methotrexate alone in the treatment of the signs and symptoms of rheumatoid arthritis over 6 months in patients with partial response to methotrexate.
NCT00036153 Study to Assess Efficacy of Tacrolimus + Methotrexate Versus Placebo + Methotrexate in Treatment of Rheumatoid Arthritis Completed Astellas Pharma Inc Phase 3 2002-03-01 The purpose of this study is to evaluate the efficacy of the combination of tacrolimus + methotrexate compared to methotrexate alone in the treatment of the signs and symptoms of rheumatoid arthritis over 6 months in patients with partial response to methotrexate.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Prograf

Condition Name

Condition Name for Prograf
Intervention Trials
Kidney Transplantation 31
Liver Transplantation 17
Renal Failure 9
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Condition MeSH

Condition MeSH for Prograf
Intervention Trials
Renal Insufficiency 21
Leukemia 12
Graft vs Host Disease 12
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Clinical Trial Locations for Prograf

Trials by Country

Trials by Country for Prograf
Location Trials
United States 388
China 41
Canada 33
France 20
Korea, Republic of 19
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Trials by US State

Trials by US State for Prograf
Location Trials
California 32
Ohio 28
Pennsylvania 23
New York 22
Texas 22
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Clinical Trial Progress for Prograf

Clinical Trial Phase

Clinical Trial Phase for Prograf
Clinical Trial Phase Trials
Phase 4 76
Phase 3 30
Phase 2/Phase 3 5
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Clinical Trial Status

Clinical Trial Status for Prograf
Clinical Trial Phase Trials
Completed 97
Not yet recruiting 32
Recruiting 31
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Clinical Trial Sponsors for Prograf

Sponsor Name

Sponsor Name for Prograf
Sponsor Trials
Astellas Pharma Inc 34
National Cancer Institute (NCI) 19
Veloxis Pharmaceuticals 14
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Sponsor Type

Sponsor Type for Prograf
Sponsor Trials
Other 142
Industry 141
NIH 22
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