Safety and Pharmacokinetics Study of DU-176b Administered to Non-valvular Atrial Fibrillation With Severe Renal Impairment

NCT01857622 | Completed Phase 3 Results DMC

• 1 other identifier: DU176b-B-J307
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the safety and pharmacokinetics of DU-176b administered to non-valvular atrial fibrillation patients with severe renal impairment, compared with DU-176b administered to non-valvular atrial fibrillation (NVAF) patients with normal renal function or mild renal impairment (Normal/MiRI).

Conditions

Non-valvular Atrial Fibrillation

Keywords

anticoagulant; DU-176b; edoxaban; factor Xa; oral; atrial fibrillation; severe renal impairment

Outcome Measures

Primary Outcomes (1)

• Incidence of Any Adjudicated Bleeding Events

  Incidence of any adjudicated bleeding events (including major bleeding, clinically relevant non-major bleeding, and minor bleeding)

  3 months

Study Arms (3)

SRI 15mg

EXPERIMENTAL

DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks.

Drug: DU-176b 15mg

Normal/MiRI low-dose group

EXPERIMENTAL

DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors (body weight of ≤ 60 kg or the presence of concurrent treatment with quinidine or verapamil). DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.

Drug: DU-176b 30mg

Normal/MiRI high-dose group

EXPERIMENTAL

DU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.

Drug: DU-176b 60mg

Interventions

DU-176b 15mg DRUG

oral DU-176b 15mg once daily

Also known as: edoxaban

SRI 15mg

DU-176b 30mg DRUG

oral DU-176b 30mg once daily

Also known as: edoxaban

Normal/MiRI low-dose group

DU-176b 60mg DRUG

oral DU-176b 60mg once daily

Also known as: edoxaban

Normal/MiRI high-dose group

Eligibility Criteria

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

You may qualify if:

• Patients with NVAF and SRI, or patients with NVAF and Normal/MiRI.

You may not qualify if:

• Patients who are on hemodialysis or patients who may start hemodialysis before the follow-up assessment
• Patients who are at a significantly high risk for bleeding
• Patients who are receiving treatment with any anticoagulant drugs excluding warfarin, rivaroxaban, and dabigatran
• Patients who have evidence of hepatic function test abnormalities

Sponsors & Collaborators

• Daiichi Sankyo Co., Ltd.: lead

Study Sites (1)

Tokyo Women's Medical University Hospital

Tokyo, 162-0054, Japan

Location

MeSH Terms

Conditions

Atrial Fibrillation; Renal Insufficiency

Interventions

edoxaban

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Kenichi Sakakura, Manager
• Organization: Daiichi Sankyo.,LTD

sakakura.kenichi.ef@daiichisankyo.co.jp

81-90-1885-0271

Study Officials

• Yukihiro Koretsune, Dir

  Osaka National 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: November 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: March 5, 2019
• Results First Posted: January 26, 2015

Record last verified: 2015-01

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)