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

Daiichi Sankyo

Status and phase: Completed; Phase 3

Conditions: Venous Thromboembolism

Treatments: Drug: Fondaparinux; Drug: 15mg DU-176b; Drug: 30mg DU-176b

Study type: Interventional

Funder types: Industry

Identifiers

NCT01857583

DU176b-B-J306

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

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

Experimental group

Description:

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

Treatment:

Drug: 15mg DU-176b

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

Experimental group

Description:

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

Treatment:

Drug: 30mg DU-176b

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

Active Comparator group

Description:

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

Treatment:

Drug: Fondaparinux

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

Experimental group

Description:

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

Treatment:

Drug: 15mg DU-176b