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

Phase III Clinical Study of DU-176b (Venous Thromboembolism): Japanese, Multicenter, Open-label Study of DU-176b in Patients With Severe Renal Impairment (SRI) Undergoing Orthopedic Surgery of the Lower Limbs

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.

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