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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SRI 15mg (15 mL/min ≤ CLCR < 20mL/min) | Experimental | Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days. |
|
| MiRI 30mg (50 mL/min ≤ CLCR ≤ 80mL/min) | Experimental | Mild Renal Impairment group orally administered 30mg DU-176b once daily for 14 days. |
|
| Fondaparinux (20 mL/min ≤ CLCR < 30mL/min) | Active Comparator | Fondaparinux subcutaneously administered at a dose of 1.5mg once daily for 14 days. |
|
| SRI 15mg (20 mL/min ≤ CLCR < 30mL/min) | Experimental | Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 15mg DU-176b | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Any Adjudicated Bleeding Events | Incidence of any adjudicated bleeding events (including major bleeding, clinically relevant non-major bleeding, and minor bleeding). | 14 days |
| Incidence of Adverse Events | 1 month | |
| Incidence of Adverse Drug Reactions | 1 month | |
| Plasma Concentration of DU-176b | 14 days | |
| Plasma Concentration of D21-2393 | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adjudicated Thromboembolic Events | Incidence of adjudicated thromboembolic events (symptomatic Deep Vein Thrombosis (DVT), symptomatic Pulmonary Thromboembolism (PTE), Venous Thromboembolism (VTE) related deaths). | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Takeshi Fuji, VP | Osaka Koseinenkin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toyooka Chuo Hospital | Asahikawa | Hokkaido Prefecture | 078-8237 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25653574 | Derived | 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. |
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De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | MiRI 30mg DU176b (50 mL/Min ≤ CLCR ≤ 80mL/Min) | Mild Renal Impairment group orally administered 30mg DU176b once daily for 14 days. (50 mL/min ≤ CLCR ≤ 80 mL/min) 30mg DU-176b |
| FG001 | SRI 15mg DU176b (15 mL/Min ≤ CLCR < 20 mL/Min) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 30mg DU-176b | Drug |
|
|
| Fondaparinux | Drug |
|
Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days.
(15 mL/min ≤ CLCR < 20 mL/min) 15mg DU-176b
| FG002 | SRI 15mg DU176b (20 mL/Min ≤ CLCR < 30 mL/Min) | Severe Renal Impairment group orally administered 15mg DU176b once daily for 14 days. (20 mL/min ≤ CLCR < 30 mL/min) 15mg DU-176b |
| FG003 | Fondaparinux (20 mL/Min ≤ CLCR < 30mL/Min) | Fondaparinux subcutaneously administered at a dose of 1.5mg once daily for 14 days. (20 mL/min ≤ CLCR < 30mL/min) Fondaparinux |
| Safety Analysis Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The number of baseline participants reflects the safety analysis population.
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| ID | Title | Description |
|---|---|---|
| BG000 | MiRI 30mg DU176b (50 mL/Min ≤ CLCR ≤ 80 mL/Min) | Mild Renal Impairment group orally administered 30mg DU176b once daily for 14 days. (50 mL/min ≤ CLCR ≤ 80 mL/min) 30mg DU-176b |
| BG001 | SRI 15mg DU176b (15 mL/Min ≤ CLCR < 20 mL/Min) | Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days. (15 mL/min ≤ CLCR < 20 mL/min) 15mg DU-176b |
| BG002 | SRI 15mg DU176b (20 mL/Min ≤ CLCR < 30 mL/Min) | Severe Renal Impairment group orally administered 15mg DU176b once daily for 14 days. (20 mL/min ≤ CLCR < 30 mL/min) 15mg DU-176b |
| BG003 | Fondaparinux (20 mL/Min ≤ CLCR < 30mL/Min) | Fondaparinux subcutaneously administered at a dose of 1.5mg once daily for 14 days. (20 mL/min ≤ CLCR < 30mL/min) |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Any Adjudicated Bleeding Events | Incidence of any adjudicated bleeding events (including major bleeding, clinically relevant non-major bleeding, and minor bleeding). | The safety analysis set was defined as all subjects who were enrolled in the study, except for those who had significant GCP violations, who had not received the study drug, or who had no safety data after the start of study treatment. | Posted | Number | 95% Confidence Interval | percentage of subjects with bleeds | 14 days |
|
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Incidence of Adverse Events | Not Posted | 1 month | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Incidence of Adverse Drug Reactions | Not Posted | 1 month | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Plasma Concentration of DU-176b | Not Posted | 14 days | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Plasma Concentration of D21-2393 | Not Posted | 14 days | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Adjudicated Thromboembolic Events | Incidence of adjudicated thromboembolic events (symptomatic Deep Vein Thrombosis (DVT), symptomatic Pulmonary Thromboembolism (PTE), Venous Thromboembolism (VTE) related deaths). | Not Posted | 1 month | Participants |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MiRI 30mg DU 176b (50 mL/Min ≤ CLCR ≤ 80 mL/Min) | Mild Renal Impairment group orally administered 30mg DU176b once daily for 14 days. (50 mL/min ≤ CLCR ≤ 80 mL/min) 30mg DU-176b | 1 | 30 | 22 | 30 | ||
| EG001 | SRI 15mg DU 176b (15 mL/Min ≤ CLCR < 20 mL/Min) | Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days. (15 mL/min ≤ CLCR < 20 mL/min) 15mg DU-176b | 3 | 7 | 6 | 7 | ||
| EG002 | SRI 15mg DU 176b (20 mL/Min ≤ CLCR < 30 mL/Min) | Severe Renal Impairment group orally administered 15mg DU176b once daily for 14 days. (20 mL/min ≤ CLCR < 30 mL/min) 15mg DU-176b | 2 | 22 | 12 | 22 | ||
| EG003 | Fondaparinux (20 mL/Min ≤ CLCR < 30mL/Min) | Fondaparinux subcutaneously administered at a dose of 1.5mg once daily for 14 days. Fondaparinux (20 mL/min ≤ CLCR < 30mL/min) | 3 | 20 | 12 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cardiac failure | Cardiac disorders | MedDRA/J V.15.1 | Systematic Assessment |
| |
| cardiac failure acute | Cardiac disorders | MedDRA/J V.15.1 | Systematic Assessment |
| |
| dementia | Nervous system disorders | MedDRA/J V.15.1 | Systematic Assessment |
| |
| cerebral infarction | Nervous system disorders | MedDRA/J V.15.1 | Systematic Assessment |
| |
| pyelonephritis | Infections and infestations | MedDRA/J V.15.1 | Systematic Assessment |
| |
| femur fracture | Injury, poisoning and procedural complications | MedDRA/J V.15.1 | Systematic Assessment |
| |
| joint dislocation | Injury, poisoning and procedural complications | MedDRA/J V.15.1 | Systematic Assessment |
| |
| sepsis | Infections and infestations | MedDRA/J V.15.1 | Systematic Assessment |
| |
| periprosthetic fracture | Injury, poisoning and procedural complications | MedDRA/J V.15.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cystitis | Infections and infestations | MedDRA/J V.15.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA/J V.15.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA/J V.15.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA/J V.15.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA/J V.15.1 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA/J V.15.1 | Systematic Assessment |
| |
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA/J V.15.1 | Systematic Assessment |
| |
| Chondrocalcinosis pyrophosphate | Musculoskeletal and connective tissue disorders | MedDRA/J V.15.1 | Systematic Assessment |
| |
| pubic pain | Musculoskeletal and connective tissue disorders | MedDRA/J V.15.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA/J V.15.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA/J V.15.1 | Systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA/J V.15.1 | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA/J V.15.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA/J V.15.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA/J V.15.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA/J V.15.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA/J V.15.1 | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA/J V.15.1 | Systematic Assessment |
| |
| Fibrin D dimer increased | Investigations | MedDRA/J V.15.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA/J V.15.1 | Systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA/J V.15.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA/J V.15.1 | Systematic Assessment |
| |
| Red blood cells urine positive | Infections and infestations | MedDRA/J V.15.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA/J V.15.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA/J V.15.1 | Systematic Assessment |
| |
| contusion | Injury, poisoning and procedural complications | MedDRA/J V.15.1 | Systematic Assessment |
| |
| Wound haemorrhage | Injury, poisoning and procedural complications | MedDRA/J V.15.1 | Systematic Assessment |
| |
| Periprosthetic fracture | Injury, poisoning and procedural complications | MedDRA/J V.15.1 | Systematic Assessment |
| |
| Wound haematoma | Injury, poisoning and procedural complications | MedDRA/J V.15.1 | Systematic Assessment |
|
PI shall not publish the results of the Study at any time without the prior written approval of Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Masayuki Fukuzawa, Associate Director | Daiichi Sankyo.,LTD | 81-90-5584-2197 | fukuzawa.masayuki.gn@daiichisankyo.co.jp |
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C552171 | edoxaban |
| D000077425 | Fondaparinux |
| ID | Term |
|---|---|
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Cox Proportional Hazard |
| 17.3 |
| 2-Sided |
| 95 |
| -10.2 |
| 42.1 |
| Superiority or Other |