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

Phase 3

Completed

• Conditions: Venous Thromboembolism
• Interventions: Drug: 15mg DU-176b; Drug: 30mg DU-176b; Drug: Fondaparinux

• Registration Number: NCT01857583
• Lead Sponsor: Daiichi Sankyo Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2013-05-16
• Study First Submitted QC: 2013-05-16
• Study First Posted: 2013-05-20
• Results First Submitted: 2015-01-15
• Results First Submitted QC: 2015-01-15
• Results First Posted: 2015-01-26
• Status Verified: 2015-02
• Last Update Submitted: 2019-02-08
• Last Update Posted: 2019-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SRI 15mg (15 mL/min ≤ CLCR < 20mL/min)	15mg DU-176b	Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days.
SRI 15mg (20 mL/min ≤ CLCR < 30mL/min)	15mg DU-176b	Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days.
MiRI 30mg (50 mL/min ≤ CLCR ≤ 80mL/min)	30mg DU-176b	Mild Renal Impairment group orally administered 30mg DU-176b once daily for 14 days.
Fondaparinux (20 mL/min ≤ CLCR < 30mL/min)	Fondaparinux	Fondaparinux subcutaneously administered at a dose of 1.5mg once daily for 14 days.

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Drug Reactions	1 month
Plasma Concentration of DU-176b	14 days
Plasma Concentration of D21-2393	14 days
Incidence of Any Adjudicated Bleeding Events	14 days	Incidence of any adjudicated bleeding events (including major bleeding, clinically relevant non-major bleeding, and minor bleeding).
Incidence of Adverse Events	1 month

Secondary Outcome Measures

Name	Time	Method
Incidence of Adjudicated Thromboembolic Events	1 month	Incidence of adjudicated thromboembolic events (symptomatic Deep Vein Thrombosis (DVT), symptomatic Pulmonary Thromboembolism (PTE), Venous Thromboembolism (VTE) related deaths).

Trial Locations

Locations (1)

Toyooka Chuo Hospital; 🇯🇵 Asahikawa, Hokkaido Prefecture, Japan