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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000964-28 | EudraCT Number | ||
| KAI-4169 | Other Identifier | KAI Pharmaceuticals (wholly owned subsidiary of Amgen Inc.) |
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This is a multicenter, multiple-dose, single-arm, open-label study to assess the impact on serum corrected calcium levels when switching patients from cinacalcet to etelcalcetide (AMG 416).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etelcalcetide | Experimental | Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etelcalcetide | Drug | Etelcalcetide is provided as a sterile lyophilized powder to be reconstituted with sterile water for injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL During the 4-week Treatment Period | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Parathyroid Hormone During the Treatment Period | Baseline and weeks 2, 3 and 4 | |
| Percentage of Participants With Serum Corrected Calcium < 8.3 mg/dL During the 4-week Treatment Period | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | From the first dose of study drug up to 30 days after the last dose; 8 weeks | |
| Percentage of Participants With Symptomatic Hypocalcemia During the 4-week Treatment Period | Hpocalcemia was used for events of decreased calcium accompanied by clinical signs and symptoms of hypocalcemia. |
Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Alhambra | California | 91801 | United States | ||
| Research Site |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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Upon enrollment, participants underwent a washout period of a minimum of 7 days, wherein no cinacalcet use was allowed. Participants who had a serum corrected calcium ≥ 8.3 mg/dL during the washout period entered the treatment phase and were categorized based on their pre-washout, screening cinacalcet daily dose level (30 mg, 60 mg or ≥ 90 mg).
This study was conducted at 33 centers in the United States. Participants were enrolled from 1 September 2013 to 9 December 2013.
Participants were required to be on a stable dose of daily oral cinacalcet for a minimum of 4 weeks before screening, and during the 4 weeks of screening.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etelcalcetide | Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| From the first dose of study drug up to 30 days after the last dose; 8 weeks |
| Azusa |
| California |
| 91702 |
| United States |
| Research Site | Bakersfield | California | 93308 | United States |
| Research Site | Chula Vista | California | 91910 | United States |
| Research Site | La Mesa | California | 91942 | United States |
| Research Site | Los Angeles | California | 90022 | United States |
| Research Site | Lynwood | California | 90262 | United States |
| Research Site | Riverside | California | 92505 | United States |
| Research Site | Whittier | California | 90603 | United States |
| Research Site | Arvada | Colorado | 80002 | United States |
| Research Site | North Haven | Connecticut | 06473 | United States |
| Research Site | Coral Springs | Florida | 33071 | United States |
| Research Site | Hollywood | Florida | 33021 | United States |
| Research Site | Miami | Florida | 33150 | United States |
| Research Site | Pembroke Pines | Florida | 33028 | United States |
| Research Site | Pinecrest | Florida | 33156 | United States |
| Research Site | Tampa | Florida | 33614 | United States |
| Research Site | Augusta | Georgia | 30909 | United States |
| Research Site | Evergreen Park | Illinois | 60805 | United States |
| Research Site | Michigan City | Indiana | 46360 | United States |
| Research Site | Baton Rouge | Louisiana | 70808 | United States |
| Research Site | Lafayette | Louisiana | 70506 | United States |
| Research Site | Columbus | Mississippi | 39705 | United States |
| Research Site | Gulfport | Mississippi | 39501 | United States |
| Research Site | Farmington | Missouri | 63640 | United States |
| Research Site | Kansas City | Missouri | 64111 | United States |
| Research Site | St Louis | Missouri | 63136 | United States |
| Research Site | Portsmouth | New Hampshire | 03801 | United States |
| Research Site | Eatontown | New Jersey | 07724 | United States |
| Research Site | College Point | New York | 11356 | United States |
| Research Site | Oklahoma City | Oklahoma | 73116 | United States |
| Research Site | Philadelphia | Pennsylvania | 19106 | United States |
| Research Site | Orangeburg | South Carolina | 29118 | United States |
| Research Site | Arlington | Texas | 76015 | United States |
| Research Site | Greenville | Texas | 75402 | United States |
| Research Site | Houston | Texas | 77004 | United States |
| Research Site | McAllen | Texas | 78503 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| Research Site | Fairfax | Virginia | 22033 | United States |
| Research Site | Hampton | Virginia | 23666 | United States |
| Received Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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Full analysis set includes iall participants who enrolled into the study and had at least one dose of etelcalcetide and at least one post-baseline serum corrected calcium value.
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| ID | Title | Description |
|---|---|---|
| BG000 | Etelcalcetide | Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks. |
| 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 |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race | Number | participants |
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| Ethnicity | Number | participants |
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| Corrected Calcium | When albumin was less than 4.0 g/dL, the calcium level was corrected according to the following formula: Corrected calcium (cCa) (mg/dL) = total Ca (mg/dL) + (4 - albumin [g/dL]) * 0.8. | Mean | Standard Deviation | mg/dL |
| |||||||||||||||||||||
| Parathyroid Hormone | Data available for 140 participants | Mean | Standard Deviation | pg/mL |
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| Phosphorus | Data available for 135 participants | Mean | Standard Deviation | mg/dL |
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| 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 Serum Corrected Calcium < 7.5 mg/dL During the 4-week Treatment Period | Full analysis set | Posted | Number | 95% Confidence Interval | percentage of participants | 4 weeks |
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| Secondary | Percent Change From Baseline in Parathyroid Hormone During the Treatment Period | Full analysis set with available data at each time point | Posted | Mean | Standard Error | percent change | Baseline and weeks 2, 3 and 4 |
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| Secondary | Percentage of Participants With Serum Corrected Calcium < 8.3 mg/dL During the 4-week Treatment Period | Full analysis set | Posted | Number | 95% Confidence Interval | percentage of participants | 4 weeks |
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| Other Pre-specified | Number of Participants With Adverse Events | All participants who received at least one dose of study drug | Posted | Number | participants | From the first dose of study drug up to 30 days after the last dose; 8 weeks |
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| Other Pre-specified | Percentage of Participants With Symptomatic Hypocalcemia During the 4-week Treatment Period | Hpocalcemia was used for events of decreased calcium accompanied by clinical signs and symptoms of hypocalcemia. | Participants who received at least one dose of study drug | Posted | Number | 95% Confidence Interval | percentage of participants | From the first dose of study drug up to 30 days after the last dose; 8 weeks |
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From the first dose of study drug up to 30 days after the last dose; up to 8 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
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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 | Etelcalcetide | Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks. | 17 | 148 | 0 | 148 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Bile duct obstruction | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
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| Arteriovenous graft site infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Biliary sepsis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Osteomyelitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Staphylococcal bacteraemia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA 16.1 | Systematic Assessment |
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| Fluid overload | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Mental status changes | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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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 |
| D051436 | Renal Insufficiency, Chronic |
| D006996 | Hypocalcemia |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014883 | Water-Electrolyte Imbalance |
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| ID | Term |
|---|---|
| C583569 | etelcalcetide hydrochloride |
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| Black (or African American) |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Title | Denominators | Categories |
|---|
| Week 2 (n = 125) |
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| Week 3 (n = 131) |
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| Week 4 (n = 123) |
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| Title | Denominators | Categories |
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| Title | Denominators | Categories |
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| Any adverse event (AE) |
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| Serious adverse event (SAE) |
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| AE leading to discontinuation of etelcalcetide |
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| Fatal adverse event |
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| Treatment-related adverse event |
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