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Last Updated: December 12, 2019

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CLINICAL TRIALS PROFILE FOR NALFURAFINE

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Clinical Trials for Nalfurafine

Trial ID Title Status Sponsor Phase Summary
NCT00638495 Phase II Study of TRK-820 Soft Capsules — Intractable Pruritus in Patients With Chronic Liver Disease — Completed Toray Industries, Inc Phase 2 The efficacy and safety of TRK-820 are to be evaluated in the treatment of intractable pruritus in patients with Chronic Liver Disease by administering 2.5, 5 and 10 microg of this drug or placebo for 28 days in four groups with a design of randomized, double-blind, parallel-group comparison. In addition, the plasma concentrations of TRK-820 and its primary metabolites are to be determined.
NCT00793156 A Randomized-Withdrawal Phase 3 Study Evaluating the Safety and Efficacy of Oral Nalfurafine HCl (AC-820)in Subjects on Hemodialysis With Uremic Pruritus (Renal Itch) Unknown status Acologix, Inc. Phase 3 Primary objective of this multicenter, double-blind, placebo controlled, randomized withdrawal study are to determine the effectiveness and safety of orally administered AC-820 in doses of 2.5 µg and 5.0 µg daily in patients with moderate to severe itching associated with end-stage renal disease and hemodialysis, and perform a population PK analysis.
NCT01248650 Safety Study of TRK-820 for Patient With Hemodialysis Completed Toray Industries, Inc Phase 1 The purpose of this study is to observe pharmacokinetics and safety of nalfurafine hydrochloride in patients receiving hemodialysis.
NCT01248650 Safety Study of TRK-820 for Patient With Hemodialysis Completed SK Chemicals Co.,Ltd. Phase 1 The purpose of this study is to observe pharmacokinetics and safety of nalfurafine hydrochloride in patients receiving hemodialysis.
NCT01513161 Efficacy and Safety Study of TRK-820 to Treat Conventional-treatment-resistant Pruritus in Patients Receiving Hemodialysis Completed Toray Industries, Inc Phase 3 The purpose of this study is to determine whether nalfurafine hydrochloride is effective and safe in the treatment for conventional-treatment-resistant pruritus in patients receiving hemodialysis.
NCT01513161 Efficacy and Safety Study of TRK-820 to Treat Conventional-treatment-resistant Pruritus in Patients Receiving Hemodialysis Completed SK Chemicals Co.,Ltd. Phase 3 The purpose of this study is to determine whether nalfurafine hydrochloride is effective and safe in the treatment for conventional-treatment-resistant pruritus in patients receiving hemodialysis.
NCT01660243 Efficacy and Safety of MT-9938 for Treatment of Uremic Pruritus in Subjects With End-stage Renal Disease Receiving Hemodialysis Terminated Toray Industries, Inc Phase 2 This study is being conducted to investigate the efficacy of MT-9938 compared with placebo after 2 weeks, to continue to evaluate efficacy for an additional 6 weeks, and to explore the effect of a reduction in itching intensity on health-related Quality of Life(QoL) domains, especially those which recent research suggests have a positive correlation with overall survival for this patient group. The study will consist of the following phases: Screening (1 to 2 weeks), Run in (1 week), double-blind Treatment (8 weeks), Washout (1 week) culminating in a Follow-up Visit (1 week after the last dose).
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Nalfurafine

Condition Name

Condition Name for
Intervention Trials
Uremic Pruritus 3
Pruritus With Chronic Liver Disease 1
Conventional-treatment-resistant Pruritus in Patients Receiving Hemodialysis 1
Chronic Renal Failure 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Pruritus 5
Kidney Failure, Chronic 2
Renal Insufficiency 1
Liver Diseases 1
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Clinical Trial Locations for Nalfurafine

Trials by Country

Trials by Country for
Location Trials
United States 3
Korea, Republic of 2
Germany 1
Japan 1
Bulgaria 1
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Trials by US State

Trials by US State for
Location Trials
Texas 1
New York 1
California 1
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Clinical Trial Progress for Nalfurafine

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 3 2
Phase 2 2
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Completed 3
Unknown status 1
Recruiting 1
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Clinical Trial Sponsors for Nalfurafine

Sponsor Name

Sponsor Name for
Sponsor Trials
Toray Industries, Inc 5
SK Chemicals Co.,Ltd. 2
Acologix, Inc. 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 8
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