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

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.

Timeline

Start

2012-03

Primary completion

2012-12

Completion

2012-12

Publications

• 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.

Drugs

Indications