Phase 3
N=80
Safety and Pharmacokinetics Study of DU-176b Administered to Patients With Severe Renal Impairment Undergoing Orthopedic Surgery of The Lower Limbs
Venous Thromboembolism
Bottom Line
View on ClinicalTrials.gov: NCT01857583 ↗Enrolled (actual)
80
Serious AEs
11.4%
Results posted
Jan 2015
Primary outcome: Primary: Incidence of Any Adjudicated Bleeding Events — 33.3; 14.3; 22.7; 40.0 percentage of subjects with bleeds
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 15mg DU-176b (Drug); 30mg DU-176b (Drug); Fondaparinux (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Daiichi Sankyo Co., Ltd.
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Any Adjudicated Bleeding Events |
33.3; 14.3; 22.7; 40.0 | — |
| PRIMARY Incidence of Adverse Events |
— | — |
| PRIMARY Incidence of Adverse Drug Reactions |
— | — |
| PRIMARY Plasma Concentration of DU-176b |
— | — |
| PRIMARY Plasma Concentration of D21-2393 |
— | — |
| SECONDARY Incidence of Adjudicated Thromboembolic Events |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01857583). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.