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

Venous Thromboembolism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01857583
• Other study ID #: DU176b-B-J306
• Status: Completed
• Phase: Phase 3
• Start date: March 2012
• Est. completion date: December 2012

Study information

• Verified date: February 2015
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Renal Insufficiency
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• 15mg DU-176b

• 30mg DU-176b

• Fondaparinux

Locations

Country	Name	City	State
Japan	Toyooka Chuo Hospital	Asahikawa	Hokkaido Prefecture

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Any Adjudicated Bleeding Events	Incidence of any adjudicated bleeding events (including major bleeding, clinically relevant non-major bleeding, and minor bleeding).	14 days
Primary	Incidence of Adverse Events		1 month
Primary	Incidence of Adverse Drug Reactions		1 month
Primary	Plasma Concentration of DU-176b		14 days
Primary	Plasma Concentration of D21-2393		14 days
Secondary	Incidence of Adjudicated Thromboembolic Events	Incidence of adjudicated thromboembolic events (symptomatic Deep Vein Thrombosis (DVT), symptomatic Pulmonary Thromboembolism (PTE), Venous Thromboembolism (VTE) related deaths).	1 month