Conditions: Venous Thromboembolism
Keywords: anticoagulant DU-176b edoxaban factor Xa oral orthopedic surgery of lower limbs severe renal impairment
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 80
Healthy volunteers: no

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:

Arms:
arm 1: Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days. arm 2: Mild Renal Impairment group orally administered 30mg DU-176b once daily for 14 days. arm 3: Fondaparinux subcutaneously administered at a dose of 1.5mg once daily for 14 days. arm 4: Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days.

Interventions: intervention 1: 15mg DU-176b intervention 2: 30mg DU-176b intervention 3: Fondaparinux
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: