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

NCT01857583 | Completed Phase 3 Results DMC

• 1 other identifier: DU176b-B-J306
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

anticoagulant; DU-176b; edoxaban; factor Xa; oral; orthopedic surgery of lower limbs; severe renal impairment

Outcome Measures

Primary Outcomes (5)

• 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

• Incidence of Adverse Events

  1 month

• Incidence of Adverse Drug Reactions

  1 month

• Plasma Concentration of DU-176b

  14 days

• Plasma Concentration of D21-2393

  14 days

Secondary Outcomes (1)

• Incidence of Adjudicated Thromboembolic Events

  1 month

Study Arms (4)

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

EXPERIMENTAL

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

Drug: 15mg DU-176b

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

EXPERIMENTAL

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

Drug: 30mg DU-176b

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

ACTIVE COMPARATOR

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

Drug: Fondaparinux

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

EXPERIMENTAL

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

Drug: 15mg DU-176b

Interventions

15mg DU-176b DRUG

Also known as: edoxaban

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

30mg DU-176b DRUG

Also known as: edoxaban

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

Fondaparinux DRUG

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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with SRI or MiRI undergoing orthopedic surgery of the lower limbs

You may not qualify if:

• 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

Sponsors & Collaborators

• Daiichi Sankyo Co., Ltd.: lead

Study Sites (1)

Toyooka Chuo Hospital

Asahikawa, Hokkaido Prefecture, 078-8237, Japan

Location

Related Publications (1)

• 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.

  PMID: 25653574 DERIVED

MeSH Terms

Conditions

Venous Thromboembolism; Renal Insufficiency

Interventions

edoxaban; Fondaparinux

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Oligosaccharides; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Masayuki Fukuzawa, Associate Director
• Organization: Daiichi Sankyo.,LTD

fukuzawa.masayuki.gn@daiichisankyo.co.jp

81-90-5584-2197

Study Officials

• Takeshi Fuji, VP

  Osaka Koseinenkin Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2013
• First Posted: May 20, 2013
• Study Start: March 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 5, 2019
• Results First Posted: January 26, 2015

Record last verified: 2015-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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.

Locations

JP (1)