Not provided
Not provided
Not provided
Not provided
Not provided
Development of SRM003 was discontinued based on portfolio prioritization.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A study to evaluate the efficacy of SRM003 treatment versus participating sites' standard practice treatment in extending the duration of primary patency after arteriovenous graft surgery in subjects with end-stage renal disease.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SRM003 | Active Comparator |
| |
| Participating Site's standard practice | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SRM003 | Biological | One time implant (3 SRM003 pieces) on surgery day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Loss of Unassisted Primary Patency | Unassisted primary patency (intervention--free access survival) was defined as the duration of time in days from the date of randomization (arteriovenous graft [AVG] placement) 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. Assessment of AVG patency was evaluated during physical examination of the subject's AVG at each visit and through ongoing AVG monitoring and surveillance according to each participating site's standard practice. It was recommended to follow the National Kidney Foundation Kidney guidelines (National Kidney Foundation 2006) on appropriate management and treatment of AVG complications to improve the function and longevity of the vascular access. | Up to 78 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Loss of Assisted Primary Patency | Assisted primary patency (thrombosis--free access survival) was defined as the duration of time in days from the date of randomization (AVG placement) until the first date of (a) occlusion (commonly due to thrombosis) or (b) access abandonment. Assessment of AVG patency was evaluated during physical examination of the subject's AVG at each visit and through ongoing AVG monitoring and surveillance according to each participating site's standard practice. It was recommended to follow the National Kidney Foundation Kidney guidelines (National Kidney Foundation 2006) on appropriate management and treatment of AVG complications to improve the function and longevity of the vascular access. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
| 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 78 weeks of follow-up for assessment of efficacy and safety. |
| FG001 | SRM003 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Participating Site's standard practice | Other | Subjects will receive sites' standard practice treatment during the surgical procedure |
|
| Up to 78 weeks after surgery |
| Percentage of Participants With Loss of Secondary Patency | Secondary patency (access survival until abandonment) was defined as the duration of time in days from the date of randomization (AVG placement) until the date of access abandonment. Assessment of AVG patency was evaluated during physical examination of the subject's AVG at each visit and through ongoing AVG monitoring and surveillance according to each participating site's standard practice. It was recommended to follow the National Kidney Foundation Kidney guidelines (National Kidney Foundation 2006) on appropriate management and treatment of AVG complications to improve the function and longevity of the vascular access. | Up to 78 weeks after surgery |
| Number of Interventions to Establish, Maintain, or Restore Patency | The total numbers of interventions to establish, maintain, or restore patency was assessed at the Week 26 visit. | 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 |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. After surgery, subjects were to undergo assessments during the 78-week follow-up period. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Intent-to-Treat population, defined as all randomly assigned participants regardless of the treatment received 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 78 weeks of follow-up for assessment of efficacy and safety. |
| BG001 | SRM003 | Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. After surgery, subjects were to undergo assessments during the 78-week follow-up period. |
| 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 Loss of Unassisted Primary Patency | Unassisted primary patency (intervention--free access survival) was defined as the duration of time in days from the date of randomization (arteriovenous graft [AVG] placement) 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. Assessment of AVG patency was evaluated during physical examination of the subject's AVG at each visit and through ongoing AVG monitoring and surveillance according to each participating site's standard practice. It was recommended to follow the National Kidney Foundation Kidney guidelines (National Kidney Foundation 2006) on appropriate management and treatment of AVG complications to improve the function and longevity of the vascular access. | The Intent to-Treat (ITT) population, defined as all randomly assigned participants regardless of the treatment received or having post-baseline outcome data. | Posted | Number | percentage of participants | Up to 78 weeks after surgery |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Loss of Assisted Primary Patency | Assisted primary patency (thrombosis--free access survival) was defined as the duration of time in days from the date of randomization (AVG placement) until the first date of (a) occlusion (commonly due to thrombosis) or (b) access abandonment. Assessment of AVG patency was evaluated during physical examination of the subject's AVG at each visit and through ongoing AVG monitoring and surveillance according to each participating site's standard practice. It was recommended to follow the National Kidney Foundation Kidney guidelines (National Kidney Foundation 2006) on appropriate management and treatment of AVG complications to improve the function and longevity of the vascular access. | The ITT population, defined as all randomly assigned participants regardless of the treatment received or having post-baseline outcome data. | Posted | Number | percentage of participants | Up to 78 weeks after surgery |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Loss of Secondary Patency | Secondary patency (access survival until abandonment) was defined as the duration of time in days from the date of randomization (AVG placement) until the date of access abandonment. Assessment of AVG patency was evaluated during physical examination of the subject's AVG at each visit and through ongoing AVG monitoring and surveillance according to each participating site's standard practice. It was recommended to follow the National Kidney Foundation Kidney guidelines (National Kidney Foundation 2006) on appropriate management and treatment of AVG complications to improve the function and longevity of the vascular access. | The ITT population, defined as all randomly assigned participants regardless of the treatment received or having post-baseline outcome data. | Posted | Number | percentage of participants | Up to 78 weeks after surgery |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Interventions to Establish, Maintain, or Restore Patency | The total numbers of interventions to establish, maintain, or restore patency was assessed at the Week 26 visit. | The ITT population, defined as all randomly assigned participants regardless of the treatment received or having post-baseline outcome data. | Posted | Mean | Standard Deviation | interventions | 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 78 weeks of follow-up for assessment of efficacy and safety. | 10 | 14 | 13 | 14 | ||
| EG001 | SRM003 | Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. After surgery, subjects were to undergo assessments during the 78-week follow-up period. | 10 | 18 | 17 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Autoimmune thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Bundle branch block right | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abdominal adhesions | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Arteriovenous graft site infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Arteriovenous graft site haematoma | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Graft thrombosis | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Staphylococcus test positive | Investigations | 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 |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Brain compression | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Renal mass | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dry gangrene | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Steal syndrome | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Venous stenosis | 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 |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Bundle branch block left | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cardiomegaly | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cardiovascular disorder | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Deafness unilateral | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Catheter site pain | General 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 |
| |
| Oedema | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Ulcer | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Arteriovenous graft site haemorrhage | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Graft thrombosis | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Haemodialysis complication | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Incision site hypoaesthesia | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Nerve injury | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Vascular graft complication | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Vascular graft thrombosis | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Body temperature decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Brain natriuretic peptide increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Grip strength decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Human chorionic gonadotropin positive | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Finger deformity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pain in extremity | 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 |
| |
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hallucination, visual | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Renal failure chronic | 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 |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Ingrown hair | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Arteriovenous graft | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Coronary angioplasty | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Coronary arterial stent insertion | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Dialysis | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Thrombectomy | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Peripheral coldness | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Vasospasm | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Venous stenosis | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
Study was discontinued early due to Sponsor decision.
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 |
|---|---|
| D057772 | Vascular System Injuries |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| 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 |
|
| Male |
|
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|