- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01857583
Safety and Pharmacokinetics Study of DU-176b Administered to Patients With Severe Renal Impairment Undergoing Orthopedic Surgery of The Lower Limbs
Phase III Clinical Study of DU-176b (Venous Thromboembolism): Japanese, Multicenter, Open-label Study of DU-176b in Patients With Severe Renal Impairment (SRI) Undergoing Orthopedic Surgery of the Lower Limbs
To assess the safety and pharmacokinetics of DU-176b administered to patients with severe renal impairment undergoing orthopedic surgery of the lower limbs, compared with DU-176b administered to patients with mild renal impairment (MiRI) undergoing orthopedic surgery of the lower limbs.
For reference, the safety of DU-176b in patients with SRI undergoing orthopedic surgery of the lower limbs will be compared with that of fondaparinux.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Hokkaido Prefecture
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Asahikawa, Hokkaido Prefecture, Japan, 078-8237
- Toyooka Chuo Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with SRI or MiRI undergoing orthopedic surgery of the lower limbs
Exclusion Criteria:
- Patients who are on hemodialysis or are scheduled to undergo hemodialysis during the study period
- Patients who are at a significantly high risk for bleeding or thromboembolism
- Patients who are receiving another antithrombotic therapy and are unable to suspend the therapy
- Patients who have evidence of hepatic function test abnormalities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SRI 15mg (15 mL/min ≤ CLCR < 20mL/min)
Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days.
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Other Names:
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Experimental: MiRI 30mg (50 mL/min ≤ CLCR ≤ 80mL/min)
Mild Renal Impairment group orally administered 30mg DU-176b once daily for 14 days.
|
Other Names:
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Active Comparator: Fondaparinux (20 mL/min ≤ CLCR < 30mL/min)
Fondaparinux subcutaneously administered at a dose of 1.5mg once daily for 14 days.
|
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Experimental: SRI 15mg (20 mL/min ≤ CLCR < 30mL/min)
Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Any Adjudicated Bleeding Events
Time Frame: 14 days
|
Incidence of any adjudicated bleeding events (including major bleeding, clinically relevant non-major bleeding, and minor bleeding).
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14 days
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Incidence of Adverse Events
Time Frame: 1 month
|
1 month
|
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Incidence of Adverse Drug Reactions
Time Frame: 1 month
|
1 month
|
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Plasma Concentration of DU-176b
Time Frame: 14 days
|
14 days
|
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Plasma Concentration of D21-2393
Time Frame: 14 days
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14 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Adjudicated Thromboembolic Events
Time Frame: 1 month
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Incidence of adjudicated thromboembolic events (symptomatic Deep Vein Thrombosis (DVT), symptomatic Pulmonary Thromboembolism (PTE), Venous Thromboembolism (VTE) related deaths).
|
1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Takeshi Fuji, VP, Osaka Koseinenkin Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Kidney Diseases
- Urologic Diseases
- Embolism and Thrombosis
- Renal Insufficiency
- Thromboembolism
- Venous Thromboembolism
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Protease Inhibitors
- Factor Xa Inhibitors
- Antithrombins
- Serine Proteinase Inhibitors
- Anticoagulants
- Edoxaban
- Fondaparinux
- PENTA
Other Study ID Numbers
- DU176b-B-J306
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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