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Safety and Pharmacokinetics Study of DU-176b Administered to Patients With Severe Renal Impairment Undergoing Orthopedic Surgery of The Lower Limbs

Primary Purpose

Venous Thromboembolism

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
15mg DU-176b
30mg DU-176b
Fondaparinux
Sponsored by
Daiichi Sankyo Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolism focused on measuring anticoagulant, DU-176b, edoxaban, factor Xa, oral, orthopedic surgery of lower limbs, severe renal impairment

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Toyooka Chuo Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Experimental

Arm Label

SRI 15mg (15 mL/min ≤ CLCR < 20mL/min)

MiRI 30mg (50 mL/min ≤ CLCR ≤ 80mL/min)

Fondaparinux (20 mL/min ≤ CLCR < 30mL/min)

SRI 15mg (20 mL/min ≤ CLCR < 30mL/min)

Arm Description

Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days.

Mild Renal Impairment group orally administered 30mg DU-176b once daily for 14 days.

Fondaparinux subcutaneously administered at a dose of 1.5mg once daily for 14 days.

Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days.

Outcomes

Primary Outcome Measures

Incidence of Any Adjudicated Bleeding Events
Incidence of any adjudicated bleeding events (including major bleeding, clinically relevant non-major bleeding, and minor bleeding).
Incidence of Adverse Events
Incidence of Adverse Drug Reactions
Plasma Concentration of DU-176b
Plasma Concentration of D21-2393

Secondary Outcome Measures

Incidence of Adjudicated Thromboembolic Events
Incidence of adjudicated thromboembolic events (symptomatic Deep Vein Thrombosis (DVT), symptomatic Pulmonary Thromboembolism (PTE), Venous Thromboembolism (VTE) related deaths).

Full Information

First Posted
May 16, 2013
Last Updated
February 8, 2019
Sponsor
Daiichi Sankyo Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01857583
Brief Title
Safety and Pharmacokinetics Study of DU-176b Administered to Patients With Severe Renal Impairment Undergoing Orthopedic Surgery of The Lower Limbs
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
Keywords
anticoagulant, DU-176b, edoxaban, factor Xa, oral, orthopedic surgery of lower limbs, severe renal impairment

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SRI 15mg (15 mL/min ≤ CLCR < 20mL/min)
Arm Type
Experimental
Arm Description
Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days.
Arm Title
MiRI 30mg (50 mL/min ≤ CLCR ≤ 80mL/min)
Arm Type
Experimental
Arm Description
Mild Renal Impairment group orally administered 30mg DU-176b once daily for 14 days.
Arm Title
Fondaparinux (20 mL/min ≤ CLCR < 30mL/min)
Arm Type
Active Comparator
Arm Description
Fondaparinux subcutaneously administered at a dose of 1.5mg once daily for 14 days.
Arm Title
SRI 15mg (20 mL/min ≤ CLCR < 30mL/min)
Arm Type
Experimental
Arm Description
Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days.
Intervention Type
Drug
Intervention Name(s)
15mg DU-176b
Other Intervention Name(s)
edoxaban
Intervention Type
Drug
Intervention Name(s)
30mg DU-176b
Other Intervention Name(s)
edoxaban
Intervention Type
Drug
Intervention Name(s)
Fondaparinux
Primary Outcome Measure Information:
Title
Incidence of Any Adjudicated Bleeding Events
Description
Incidence of any adjudicated bleeding events (including major bleeding, clinically relevant non-major bleeding, and minor bleeding).
Time Frame
14 days
Title
Incidence of Adverse Events
Time Frame
1 month
Title
Incidence of Adverse Drug Reactions
Time Frame
1 month
Title
Plasma Concentration of DU-176b
Time Frame
14 days
Title
Plasma Concentration of D21-2393
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Incidence of Adjudicated Thromboembolic Events
Description
Incidence of adjudicated thromboembolic events (symptomatic Deep Vein Thrombosis (DVT), symptomatic Pulmonary Thromboembolism (PTE), Venous Thromboembolism (VTE) related deaths).
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takeshi Fuji, VP
Organizational Affiliation
Osaka Koseinenkin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toyooka Chuo Hospital
City
Asahikawa
State/Province
Hokkaido Prefecture
ZIP/Postal Code
078-8237
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD Sharing Time Frame
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD Sharing Access Criteria
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
IPD Sharing URL
https://vivli.org/ourmember/daiichi-sankyo/
Citations:
PubMed Identifier
25653574
Citation
Fuji T, Fujita S, Kawai Y, Abe Y, Kimura T, Fukuzawa M, Abe K, Tachibana S. A randomized, open-label trial of edoxaban in Japanese patients with severe renal impairment undergoing lower-limb orthopedic surgery. Thromb J. 2015 Jan 30;13(1):6. doi: 10.1186/s12959-014-0034-9. eCollection 2015.
Results Reference
derived

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Safety and Pharmacokinetics Study of DU-176b Administered to Patients With Severe Renal Impairment Undergoing Orthopedic Surgery of The Lower Limbs

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