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Last Updated: October 24, 2021

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CLINICAL TRIALS PROFILE FOR TACROLIMUS

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505(b)(2) Clinical Trials for tacrolimus

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 NCT00374803 ↗ Study of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal Completed Novartis Phase 4 2006-04-01 To determine the safety and efficacy of a new formulation of Myfortic in combination with tacrolimus and thymoglobulin.
New Formulation NCT00374803 ↗ Study of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal Completed University of Cincinnati Phase 4 2006-04-01 To determine the safety and efficacy of a new formulation of Myfortic in combination with tacrolimus and thymoglobulin.
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
New Combination NCT01265537 ↗ A Pilot Study Comparing the Use of Low-target Versus Conventional Target Advagraf Recruiting Astellas Pharma Canada, Inc. N/A 2012-03-01 While the incidence of acute rejection and early graft loss have improved dramatically with the advent of newer immunosuppressant medications, improvements in long-term patient and allograft survival after kidney transplantation have not been achieved. The specific drug combination that provides the best outcomes with the least amount of side effects is not known. Each kidney transplant center uses the combination of drugs that they believe is optimal. This study is about identifying whether drugs that are currently approved for use in kidney transplantation can be used in a new combination safely and with potentially fewer side effects than the drug combinations that are currently used at St. Paul's Hospital and other transplant centres.
New Combination NCT01265537 ↗ A Pilot Study Comparing the Use of Low-target Versus Conventional Target Advagraf Recruiting University of British Columbia N/A 2012-03-01 While the incidence of acute rejection and early graft loss have improved dramatically with the advent of newer immunosuppressant medications, improvements in long-term patient and allograft survival after kidney transplantation have not been achieved. The specific drug combination that provides the best outcomes with the least amount of side effects is not known. Each kidney transplant center uses the combination of drugs that they believe is optimal. This study is about identifying whether drugs that are currently approved for use in kidney transplantation can be used in a new combination safely and with potentially fewer side effects than the drug combinations that are currently used at St. Paul's Hospital and other transplant centres.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for tacrolimus

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00002792 ↗ Combination Chemotherapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloproliferative Disorders Completed National Cancer Institute (NCI) Phase 2 1996-06-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining bone marrow or peripheral stem cell transplantation with chemotherapy may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus either bone marrow or peripheral stem cell transplantation in treating patients with myeloproliferative disorders.
NCT00002792 ↗ Combination Chemotherapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloproliferative Disorders Completed Fred Hutchinson Cancer Research Center Phase 2 1996-06-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining bone marrow or peripheral stem cell transplantation with chemotherapy may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus either bone marrow or peripheral stem cell transplantation in treating patients with myeloproliferative disorders.
NCT00002809 ↗ Bone Marrow Transplant Plus Cyclophosphamide and Total-Body Irradiation in Treating Patients With Hematologic Cancer Completed Temple University Phase 2 1996-08-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy and radiation therapy together with bone marrow transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bone marrow transplant from an unrelated donor together with cyclophosphamide and total-body irradiation works in treating patients with hematologic cancer.
NCT00002831 ↗ Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous or Acute Leukemia Completed National Cancer Institute (NCI) Phase 1/Phase 2 1995-08-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of high-dose chemotherapy plus peripheral stem cell transplantation in treating patients with chronic myelogenous or acute leukemia.
NCT00002831 ↗ Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous or Acute Leukemia Completed M.D. Anderson Cancer Center Phase 1/Phase 2 1995-08-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of high-dose chemotherapy plus peripheral stem cell transplantation in treating patients with chronic myelogenous or acute leukemia.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for tacrolimus

Condition Name

Condition Name for tacrolimus
Intervention Trials
Kidney Transplantation 129
Leukemia 89
Lymphoma 75
Myelodysplastic Syndromes 61
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Condition MeSH

Condition MeSH for tacrolimus
Intervention Trials
Leukemia 173
Myelodysplastic Syndromes 127
Preleukemia 124
Graft vs Host Disease 104
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Clinical Trial Locations for tacrolimus

Trials by Country

Trials by Country for tacrolimus
Location Trials
Canada 162
France 115
Spain 109
Germany 99
Italy 84
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Trials by US State

Trials by US State for tacrolimus
Location Trials
Texas 148
California 134
Ohio 101
New York 101
Pennsylvania 88
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Clinical Trial Progress for tacrolimus

Clinical Trial Phase

Clinical Trial Phase for tacrolimus
Clinical Trial Phase Trials
Phase 4 321
Phase 3 151
Phase 2/Phase 3 30
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Clinical Trial Status

Clinical Trial Status for tacrolimus
Clinical Trial Phase Trials
Completed 460
Recruiting 244
Not yet recruiting 137
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Clinical Trial Sponsors for tacrolimus

Sponsor Name

Sponsor Name for tacrolimus
Sponsor Trials
National Cancer Institute (NCI) 139
Astellas Pharma Inc 104
M.D. Anderson Cancer Center 68
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Sponsor Type

Sponsor Type for tacrolimus
Sponsor Trials
Other 1162
Industry 521
NIH 198
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