Safety and Pharmacokinetics Study of DU-176b Administered to Non-valvular Atrial Fibrillation With Severe Renal Impairment

Study Overview
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Brief Summary
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To assess the safety and pharmacokinetics of DU-176b administered to non-valvular atrial fibrillation patients with severe renal impairment, compared with DU-176b administered to non-valvular atrial fibrillation (NVAF) patients with normal renal function or mild renal impairment (Normal/MiRI).

Official Title
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Phase III Clinical Study of DU-176b (Non-valvular Atrial Fibrillation): Japanese, Multicenter, Open-label Study of DU-176b in Patients With Non-valvular Atrial Fibrillation and Severe Renal Impairment (SRI)

Conditions
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Non-valvular Atrial Fibrillation

Intervention / Treatment
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* Drug: DU-176b 15mg
* Drug: DU-176b 30mg
* Drug: DU-176b 60mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with NVAF and SRI, or patients with NVAF and Normal/MiRI. Exclusion Criteria: Patients who are on hemodialysis or patients who may start hemodialysis before the follow-up assessment Patients who are at a significantly high risk for bleeding Patients who are receiving treatment with any anticoagulant drugs excluding warfarin, rivaroxaban, and dabigatran Patients who have evidence of hepatic function test abnormalities

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SRI 15mg<br>DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks. | Drug: DU-176b 15mg<br>* oral DU-176b 15mg once daily<br>* Other names: edoxaban;|
| Experimental: Normal/MiRI low-dose group<br>DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors (body weight of ≤ 60 kg or the presence of concurrent treatment with quinidine or verapamil). DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors. | Drug: DU-176b 30mg<br>* oral DU-176b 30mg once daily<br>* Other names: edoxaban;|
| Experimental: Normal/MiRI high-dose group<br>DU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors. | Drug: DU-176b 60mg<br>* oral DU-176b 60mg once daily<br>* Other names: edoxaban;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Any Adjudicated Bleeding Events | Incidence of any adjudicated bleeding events (including major bleeding, clinically relevant non-major bleeding, and minor bleeding) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anticoagulant, DU-176b, edoxaban, factor Xa, oral, atrial fibrillation, severe renal impairment