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Last Updated: March 2, 2021

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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
New Formulation NCT04489134 P-glypoprotein Inhibition Effect on the Pharmacokinetics of Two Tacrolimus Formulations: Prolonged and Extended-release Not yet recruiting Rennes University Hospital Phase 2 2020-09-01 Tacrolimus is a drug administered orally available with different formulations: immediate release (Prograf®), prolonged-release (Advagraf®) and an extended-release one named LCP-Tacro (Envarsus®), formulated using the Melt-Dose process. Tacrolimus is a lipophilic macrolide drug able to passive transmembrane diffusion. Its bioavailability displays a large interindividual variability, from 9 to 43%. Indeed, tacrolimus is a substrate of P-glycoprotein (P-gp) and cytochrome P450 3A4 (CYP3A4). P-gp is an efflux protein mainly located at the apex of the epithelia of the intestine, lymphocyte, kidney and blood-brain barrier. P-gp therefore limits the intestinal resorption of tacrolimus and also its diffusion into its target compartment (i.e the lymphocyte. The expression of this protein is different throughout the digestive tract with maximum expression at the ileal level. CYP3A4 is a coenzyme that is responsible of more than 90% of the metabolism of tacrolimus, at the digestive and hepatic level. Both P-gp and CYP3A4 play a role in tacrolimus absorption/diffusion process. A new formulation of tacrolimus, LCP-Tacro, (Envarsus®) was approved in 2014. Its efficacy was compared to Prograf® in two phase III de novo or switch Prograf® trials in kidney transplantation. With tacrolimus, there is a strong inter-individual pharmacokinetic variability which, to date, has not been fully characterized. Variations in bioavailability may partly explain this high variability. The different formulations are resorbed at distinct gastrointestinal sites which could explain different absorptions between Prograf/Advagraf and LCP-Tacro forms. These findings raise the question of the role of P-gp in explaining the difference in bioavailability between formulations. The use of a P-gp inhibitor could therefore have a different impact on exposure to different galenic formulations. Verapamil is an inhibitor of P-gp and CYP 3A4, which is frequently prescribed and recommended by FDA for drug-drug interaction studies aiming at evaluating P-gp substrates, used in healthy volunteers at dosages up to 240 mg/D13-14. Otherwise, verapamil-tacrolimus interaction has been characterized in vitro. It has also been shown that inhibitory effect of verapamil at a single dose of 120 mg administered one hour prior to the administration of a P-gp substrate exhibited an optimum power of inhibition. The safety of Advagraf® and Envarsus® administrations have already been subjected to several phase I trials in healthy volunteers reinforcing the knowledge of their safety profile. The aim of the study is to compare the interaction profile of Advagraf® and Envarsus® when co-administered with verapamil in healthy subjects and to provide guidelines on tacrolimus dosage adjustment in such cases.
>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 32
Liver Transplantation 17
Renal Failure 9
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Condition MeSH

Condition MeSH for Prograf
Intervention Trials
Renal Insufficiency 21
Leukemia 13
Graft vs Host Disease 13
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Clinical Trial Locations for Prograf

Trials by Country

Trials by Country for Prograf
Location Trials
United States 393
China 41
Canada 33
France 22
Korea, Republic of 19
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Trials by US State

Trials by US State for Prograf
Location Trials
California 32
Ohio 28
Texas 24
Pennsylvania 23
New York 22
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Clinical Trial Progress for Prograf

Clinical Trial Phase

Clinical Trial Phase for Prograf
Clinical Trial Phase Trials
Phase 4 77
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 38
Recruiting 34
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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) 22
Veloxis Pharmaceuticals 15
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Sponsor Type

Sponsor Type for Prograf
Sponsor Trials
Other 151
Industry 143
NIH 25
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