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A study to evaluate the efficacy of SRM003 treatment versus participating sites' standard practice treatment in improving the rate of AVF maturation and use in subjects with end-stage renal disease undergoing surgery for creation of an AVF to facilitate hemodialysis access.
It is hypothesized that when placed outside the blood vessel, the seeded SRM003 gelatin matrix containing endothelial cells can provide a continuous supply of multiple growth regulatory compounds to the underlying cells within the blood vessel, while being protected from the effects of blood flow in the vessel(s) or complications resulting from being in direct contact with the point of injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SRM003 | Active Comparator | One time implant (2 SRM003 pieces) on surgery day. Post-surgery, up to 26 weeks follow-up for assessment of efficacy/safety. |
|
| Participating Site's standard practice | Other | Subjects will receive sites' standard practice treatment during the surgical procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SRM003 | Biological | One time implant (2 SRM003 pieces) on surgery day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Arteriovenous Fistula (AVF) Maturation by Week 12 Visit Based on Hemodialysis or Color-flow Doppler Ultrasound (CDUS) And Vascular Access Examination | Maturation based on CDUS was assessed in a continuous fashion and was defined by the following criteria: presence of bruit throughout systole and diastole at least 8 centimeters (cm) proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Maturation was determined by CDUS and vascular access examination or by first use of the AVF for hemodialysis based on investigator-reported use. Participants who discontinued prior to the Week 12 visit without assessment of maturity were considered treatment failures. | 12 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With AVF Maturation by Week 26 Visit Based on Hemodialysis or CDUS And Vascular Access Examination | Maturation based on CDUS was assessed in a continuous fashion and was defined by the following criteria: presence of bruit throughout systole and diastole at least 8 centimeters (cm) proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Maturation was determined by CDUS and vascular access examination or by first use of the AVF for hemodialysis based on investigator-reported use. Participants who discontinued prior to the Week 26 visit without assessment of maturity were considered treatment failures. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akdhc Medical Research Services | Phoenix | Arizona | 85012 | United States | ||
| Tucson Vascular Consultants |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participating Site's Standard Practice | Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety. |
| FG001 | SRM003 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Participating Site's standard practice | Other | Subjects will receive sites' standard practice treatment during the surgical procedure. |
|
| 26 weeks after surgery |
| Time to AVF Maturation Based on Hemodialysis or CDUS and Vascular Access Examination | Time to AVF maturation was defined as the duration of time (in days) from the date of randomization (AVF creation) to the date of maturation, where the date of maturation corresponds to the earlier of either the date of the first use of the study AVF for hemodialysis as determined by the investigator following discussion with the participant, or the date the AVF meets all of the following 3 criteria as determined through CDUS and vascular access examination: presence of bruit throughout systole and diastole at least 8 centimeters proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Participants who died, underwent a kidney transplant, or were either lost to follow-up or did not mature during the study follow-up were censored at the time of death, time of transplant, or time of last visit, respectively. | Up to 26 weeks after surgery |
| Percentage of Participants With Loss of Unassisted Primary Patency | The time to loss of unassisted primary patency (intervention--free access survival) was defined as the duration of time in days from the date of randomization (AVF creation) until the first date of (a) any intervention designed to establish, maintain, or restore patency; (b) occlusion (commonly due to thrombosis); or (c) access abandonment. | Up to 26 weeks after surgery |
| Percentage of Participants With Loss of Assisted Primary Patency | The time to loss of assisted primary patency (thrombosis--free access survival) was defined as the duration of time in days from the date of randomization (AVF creation) until the first date of (a) occlusion (commonly due to thrombosis) or (b) access abandonment. | Up to 26 weeks after surgery |
| Percentage of Participants With Loss of Secondary Patency | The time to loss of secondary patency (access survival until abandonment) was defined as the duration of time in days from the date of randomization (AVF creation) until the date of access abandonment. | Up to 26 weeks after surgery |
| Change From Week 1 in Average Vascular Access Lumen Diameter Using CDUS | B-mode lumen diameter measurements were obtained in the outflow vein as 3 separate images for each location: at 1, 3, and 5 centimeter into the vein and from the toe of the venous anastomosis. The average of lumen diameter measurements obtained at 1, 3, and 5 cm from the anastomosis was used for this endpoint. | 1, 12, and 26 weeks after surgery |
| Percentage of Participants With Clinical Success Based on First Use of The Study AVF For Hemodialysis | Clinical success was defined as the ability to undergo hemodialysis using the AVF. The date of clinical success corresponded to the date of the first use of the study AVF for hemodialysis as determined by the investigator, following discussion with the subject. Clinical success was assessed in a continuous fashion and, once achieved, the AVF was considered a clinical success at that and all subsequent time points. The date of clinical success based on the first use of the AVF for hemodialysis was compared with the dates of each study visit (Week 12 and Week 26); for study visits occurring prior to the date of clinical success based on the first use of the AVF for hemodialysis, the subject was counted as a nonsuccess and for study visits occurring on or after the date of maturation based on the first use of the AVF for hemodialysis, the subject was counted as a success. | 12 and 26 weeks after surgery |
| Number of Interventions to Establish, Maintain, or Restore Patency | The total number of interventions to establish, maintain, or restore patency was recorded for each participant. | 12 and 26 weeks after surgery |
| Tucson |
| Arizona |
| 85745 |
| United States |
| Ladenheim Dialysis Access Center | Fresno | California | 93710 | United States |
| California Institute of Renal Research | La Mesa | California | 91942 | United States |
| VA Long Beach Health Care System Pharmacy | Long Beach | California | 90822 | United States |
| The Regents University of California Los Angeles | Los Angeles | California | 90025 | United States |
| California Institute of Renal Research | San Diego | California | 92123 | United States |
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06520-8042 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Georgia Regents University | Augusta | Georgia | 30912 | United States |
| Illinois Kidney Disease & Hypertension Center | Peoria | Illinois | 61603 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Ochsner Baptist Medical Center, Clinical Trials Unit | New Orleans | Louisiana | 70115 | United States |
| Louisiana State University Health Science Center Shreveport | Shreveport | Louisiana | 71130 | United States |
| Baystate Medical Center Pharmacy | Springfield | Massachusetts | 01199 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Renaissance Renal Research Institute, LLC | Detroit | Michigan | 48236 | United States |
| McLaren Northern Michigan Hospital-NISUS Research | Petoskey | Michigan | 49770 | United States |
| Providence Hospital, Research Dept. | Southfield | Michigan | 48075 | United States |
| Clinical Research Consultants, LLC | Kansas City | Missouri | 64111 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Sierra Nevada Nephrology Consultants | Reno | Nevada | 89511 | United States |
| United Health Services | Johnson City | New York | 13790 | United States |
| Mount Sinai School of Medicine Lab | New York | New York | 10029 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Metrolina Nephrology Associates, PA | Charlotte | North Carolina | 28204 | United States |
| ECU Department of Nephrology and Hypertension | Greenville | North Carolina | 27834 | United States |
| Sanford Research/USD-Fargo | Fargo | North Dakota | 58122 | United States |
| University of Cincinnati Physicians Company | Cincinnati | Ohio | 45267 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Toledo Hospital | Toledo | Ohio | 43560 | United States |
| Kaiser Permanente Northwest | Milwaukie | Oregon | 97267 | United States |
| Northwest Renal Clinic, Inc. | Portland | Oregon | 97210 | United States |
| Penn Medicine, Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | United States |
| Delaware Valley Nephrology and Hypertension Associates, PC | Philadelphia | Pennsylvania | 19118 | United States |
| Temple University School of Medicine | Philadelphia | Pennsylvania | 19140 | United States |
| SC Nephrology & Hypertension Center, Inc. | Orangeburg | South Carolina | 29118 | United States |
| Erlanger Hospital Pharmacy | Chattanooga | Tennessee | 37403 | United States |
| Nephrology Associates, P.C. | Nashville | Tennessee | 37205 | United States |
| Baylor College of Medicine ICTR | Houston | Texas | 77030 | United States |
| Fletcher Allen Health Care Renal Service | Burlington | Vermont | 05401 | United States |
| Sentara Vascular Specialists | Norfolk | Virginia | 23507 | United States |
| Wenatchee Valley Medical Center | Wenatchee | Washington | 98801 | United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Intent -to-Treat (ITT) population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Participating Site's Standard Practice | Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety. |
| BG001 | SRM003 | Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety. |
| BG002 | 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 |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | 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 | Percentage of Participants With Arteriovenous Fistula (AVF) Maturation by Week 12 Visit Based on Hemodialysis or Color-flow Doppler Ultrasound (CDUS) And Vascular Access Examination | Maturation based on CDUS was assessed in a continuous fashion and was defined by the following criteria: presence of bruit throughout systole and diastole at least 8 centimeters (cm) proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Maturation was determined by CDUS and vascular access examination or by first use of the AVF for hemodialysis based on investigator-reported use. Participants who discontinued prior to the Week 12 visit without assessment of maturity were considered treatment failures. | The Intent- to-Treat (ITT) population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data. | Posted | Number | percentage of participants | 12 weeks after surgery |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With AVF Maturation by Week 26 Visit Based on Hemodialysis or CDUS And Vascular Access Examination | Maturation based on CDUS was assessed in a continuous fashion and was defined by the following criteria: presence of bruit throughout systole and diastole at least 8 centimeters (cm) proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Maturation was determined by CDUS and vascular access examination or by first use of the AVF for hemodialysis based on investigator-reported use. Participants who discontinued prior to the Week 26 visit without assessment of maturity were considered treatment failures. | The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data. | Posted | Number | percentage of participants | 26 weeks after surgery |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to AVF Maturation Based on Hemodialysis or CDUS and Vascular Access Examination | Time to AVF maturation was defined as the duration of time (in days) from the date of randomization (AVF creation) to the date of maturation, where the date of maturation corresponds to the earlier of either the date of the first use of the study AVF for hemodialysis as determined by the investigator following discussion with the participant, or the date the AVF meets all of the following 3 criteria as determined through CDUS and vascular access examination: presence of bruit throughout systole and diastole at least 8 centimeters proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Participants who died, underwent a kidney transplant, or were either lost to follow-up or did not mature during the study follow-up were censored at the time of death, time of transplant, or time of last visit, respectively. | The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data. | Posted | Median | Inter-Quartile Range | days | Up to 26 weeks after surgery |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Loss of Unassisted Primary Patency | The time to loss of unassisted primary patency (intervention--free access survival) was defined as the duration of time in days from the date of randomization (AVF creation) until the first date of (a) any intervention designed to establish, maintain, or restore patency; (b) occlusion (commonly due to thrombosis); or (c) access abandonment. | The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data. | Posted | Number | percentage of participants | Up to 26 weeks after surgery |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Loss of Assisted Primary Patency | The time to loss of assisted primary patency (thrombosis--free access survival) was defined as the duration of time in days from the date of randomization (AVF creation) until the first date of (a) occlusion (commonly due to thrombosis) or (b) access abandonment. | The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data. | Posted | Number | percentage of participants | Up to 26 weeks after surgery |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Loss of Secondary Patency | The time to loss of secondary patency (access survival until abandonment) was defined as the duration of time in days from the date of randomization (AVF creation) until the date of access abandonment. | The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data. | Posted | Number | percentage of participants | Up to 26 weeks after surgery |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Week 1 in Average Vascular Access Lumen Diameter Using CDUS | B-mode lumen diameter measurements were obtained in the outflow vein as 3 separate images for each location: at 1, 3, and 5 centimeter into the vein and from the toe of the venous anastomosis. The average of lumen diameter measurements obtained at 1, 3, and 5 cm from the anastomosis was used for this endpoint. | The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data. | Posted | Mean | Standard Deviation | millimeters | 1, 12, and 26 weeks after surgery |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Success Based on First Use of The Study AVF For Hemodialysis | Clinical success was defined as the ability to undergo hemodialysis using the AVF. The date of clinical success corresponded to the date of the first use of the study AVF for hemodialysis as determined by the investigator, following discussion with the subject. Clinical success was assessed in a continuous fashion and, once achieved, the AVF was considered a clinical success at that and all subsequent time points. The date of clinical success based on the first use of the AVF for hemodialysis was compared with the dates of each study visit (Week 12 and Week 26); for study visits occurring prior to the date of clinical success based on the first use of the AVF for hemodialysis, the subject was counted as a nonsuccess and for study visits occurring on or after the date of maturation based on the first use of the AVF for hemodialysis, the subject was counted as a success. | The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data. | Posted | Number | percentage of participants | 12 and 26 weeks after surgery |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Interventions to Establish, Maintain, or Restore Patency | The total number of interventions to establish, maintain, or restore patency was recorded for each participant. | The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data. | Posted | Mean | Standard Deviation | interventions | 12 and 26 weeks after surgery |
|
Not provided
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participating Site's Standard Practice | Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety. | 16 | 29 | 17 | 29 | ||
| EG001 | SRM003 | Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety. | 13 | 35 | 25 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Non cardiac chest pain | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Steal syndrome | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Local swelling | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Medical device complication | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Arteriovenous fistula occlusion | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
| ID | Term |
|---|---|
| D001164 | Arteriovenous Fistula |
| D057772 | Vascular System Injuries |
| ID | Term |
|---|---|
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D016157 | Vascular Fistula |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D005781 | Gelatin Sponge, Absorbable |
| ID | Term |
|---|---|
| D015503 | Surgical Sponges |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
Not provided
Not provided
| ≥65 years |
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| Male |
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Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety. |
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| Participants |
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Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
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