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

NCT ID: NCT01857583

Last Updated: 2019-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2012-12-31

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.

Conditions

Venous Thromboembolism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

15mg DU-176b

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

30mg DU-176b

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

Fondaparinux

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

15mg DU-176b

Intervention Type: DRUG

Interventions

15mg DU-176b

Intervention Type: DRUG

30mg DU-176b

Intervention Type: DRUG

Fondaparinux

Intervention Type: DRUG

Other Intervention Names

edoxaban; edoxaban

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daiichi Sankyo Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Takeshi Fuji, VP

Role: PRINCIPAL_INVESTIGATOR

Osaka Koseinenkin Hospital

Locations

Toyooka Chuo Hospital

Asahikawa, Hokkaido Prefecture, Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 25653574 (View on PubMed)

Other Identifiers

DU176b-B-J306

Identifier Type: -

Identifier Source: org_study_id