Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 20120334 | Other Identifier | Amgen, Inc |
Not provided
Not provided
Not provided
Study was terminated early to allow subjects to roll over to study NCT02102204.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the long term safety and efficacy of thrice weekly intravenous (IV) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in patients receiving hemodialysis who had completed 12 weeks of treatment with etelcalcetide in parent study 20120331 (KAI-4169-005; NCT01414114).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etelcalcetide | Experimental | Participants received a bolus IV injection of etelcalcetide 3 times a week (TIW) at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etelcalcetide | Drug | Administered as an intravenous bolus three times a week at the end of each hemodialysis session at dosages up to a maximum of 15 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | From the first dose of study drug in the parent study (20120331) through 30 days after the last dose in the extension study; actual median duration of treatment was 439 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Parathyroid Hormone | Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of etelcalcetide in the parent study (20120331). The week numbering for this study continued from the parent study 20120331 hence the first measurement for all parameters in the extension study started at week 13. | Baseline (of the parent study 20120331) and Weeks 13, 26 and 52 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| M D | Amgen | Study Director |
Not provided
This study consisted of 40 weeks of treatment in extension period 1 followed by 2 years of additional treatment in extension period 2.
The Sponsor ended the study early. Participants had the opportunity to rollover into another open-label extension study 20130213 (NCT02102204).
This open-label extension study was conducted at 5 centers in the United States. Eligible participants must have completed 12 weeks of treatment in parent study 20120331 (KAI-4169-005; NCT01414114).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Etelcalcetide | Participants received a bolus intravenous (IV) injection of etelcalcetide 3 times a week (TIW) at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Extension Period 1 |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Percent Change From Baseline in Serum Corrected Calcium | Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of study drug in the parent study (20120331). The week numbering for this study continued from the parent study 20120331; the first measurement for all parameters in the extension study started at week 13. | Baseline and Weeks 13, 26 and 52 |
| Percent Change From Baseline in Serum Phosphorus | Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of study drug in the parent study (20120331). The week numbering for this study continued from the parent study 20120331; the first measurement for all parameters in the extension study started at week 13. | Baseline and Weeks 13, 26 and 52 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Extension Period 2 |
|
|
Baseline was defined as the baseline of the parent study, 20120331.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Etelcalcetide | Participants received a bolus intravenous (IV) injection of etelcalcetide 3 times a week (TIW) at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range. |
| 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 | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity | Count of Participants | Participants |
| ||||||||||||||||||
| Parathyroid Hormone | Mean | Standard Deviation | pg/mL |
| |||||||||||||||||
| Serum Corrected Calcium | Mean | Standard Deviation | mg/dL |
| |||||||||||||||||
| Serum Phosphorus | Mean | Standard Deviation | mg/dL |
|
| 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 | Number of Participants With Adverse Events | Participants who received at least one dose of etelcalcetide in the extension study | Posted | Number | participants | From the first dose of study drug in the parent study (20120331) through 30 days after the last dose in the extension study; actual median duration of treatment was 439 days. |
|
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Parathyroid Hormone | Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of etelcalcetide in the parent study (20120331). The week numbering for this study continued from the parent study 20120331 hence the first measurement for all parameters in the extension study started at week 13. | The full analysis set (all participants who received at least 1 dose during the extension study) with data collected on or before the last non-missing dose of etelcalcetide (defined as on-treatment approach). | Posted | Mean | Standard Error | percent change | Baseline (of the parent study 20120331) and Weeks 13, 26 and 52 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Serum Corrected Calcium | Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of study drug in the parent study (20120331). The week numbering for this study continued from the parent study 20120331; the first measurement for all parameters in the extension study started at week 13. | The full analysis set (all participants who received at least 1 dose during the extension study) with data collected on or before the last non-missing dose of etelcalcetide (defined as on-treatment approach). | Posted | Mean | Standard Error | percent change | Baseline and Weeks 13, 26 and 52 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Serum Phosphorus | Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of study drug in the parent study (20120331). The week numbering for this study continued from the parent study 20120331; the first measurement for all parameters in the extension study started at week 13. | The full analysis set (all participants who received at least 1 dose during the extension study) with data collected on or before the last non-missing dose of etelcalcetide (defined as on-treatment approach). | Posted | Mean | Standard Error | percent change | Baseline and Weeks 13, 26 and 52 |
|
|
From the first dose of study drug in the parent study (20120331) through 30 days after the last dose in the extension study; actual median duration of treatment was 439 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
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 | Etelcalcetide | Participants received a bolus IV injection of etelcalcetide 3 times a week at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range. | 18 | 30 | 27 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Arteriovenous fistula site infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Arteriovenous graft site infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| HIV infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Klebsiella bacteraemia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Arteriovenous graft site haemorrhage | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Vascular graft thrombosis | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Exsanguination | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Catheter site haemorrhage | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Arteriovenous fistula aneurysm | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Procedural vomiting | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Vascular graft complication | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Vascular graft thrombosis | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Blood parathyroid hormone decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Venous stenosis | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen, Inc | 866-572-6436 |
| ID | Term |
|---|---|
| D006962 | Hyperparathyroidism, Secondary |
| D012080 | Chronic Kidney Disease-Mineral and Bone Disorder |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D012279 | Rickets |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal 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 |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002128 | Calcium Metabolism Disorders |
| D014808 | Vitamin D Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C583569 | etelcalcetide hydrochloride |
Not provided
Not provided
Not provided
| Renal Transplant |
|
| Treatment Not Resumed Within 8 Weeks |
|
| Title | Measurements |
|---|---|
|
| Treatment-related serious adverse events |
|
| AEs leading to discontinuation of treatment |
|
| Fatal adverse events |
|
|
|
|