| Primary | Number of Participants With Adverse Events | | All participants who were randomized and received any amount of study medication. | Posted | | Number | | participants | | For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration. | | | | ID | Title | Description |
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| OG000 | Pooled Placebo | Participants received a single dose of placebo intravenous (IV) injection after hemodialysis. | | OG001 | Etelcalcetide 5 mg | Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis. | | OG002 | Etelcalcetide 10 mg | Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis. | | OG003 | Etelcalcetide 20 mg | Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis. | | OG004 | Etelcalcetide 40 mg | Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis. | | OG005 | Etelcalcetide 60 mg | Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis. |
| | | Title | Denominators | Categories |
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| Any adverse events | | |
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| Secondary | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | | Participants who were randomized and received any amount of study medication with available data at each time point. Only participants in Cohorts 4 and 5 had PTH assessed on days 8, 15 and 29. | Posted | | Mean | Standard Deviation | percent change | | Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, day 4 (discharge) and for Cohorts 4 and 5 only, days 8, 15 and 29 | | | | ID | Title | Description |
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| OG000 | Pooled Placebo | Participants received a single dose of placebo IV injection after hemodialysis. | | OG001 | Etelcalcetide 5 mg | Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis. | | OG002 | Etelcalcetide 10 mg | Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis. | | OG003 | Etelcalcetide 20 mg | Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis. | |
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| Secondary | Percent Change From Baseline in Serum Corrected Calcium | | Participants who were randomized and received any amount of study medication and with available data at each time point. Only participants in Cohorts 4 and 5 had serum corrected calcium assessed on days 8, 15 and 29. | Posted | | Mean | Standard Deviation | percent change | | Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, day 4 (discharge) and for Cohorts 4 and 5 only, days 8, 15 and 29 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo | Participants received a single dose of placebo IV injection after hemodialysis. | | OG001 | Etelcalcetide 5 mg | Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis. | | OG002 | Etelcalcetide 10 mg | Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis. | | OG003 | Etelcalcetide 20 mg | Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis. |
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| Secondary | Percent Change From Baseline in Ionized Calcium | | Participants who were randomized and received any amount of study medication with available data at each time point | Posted | | Mean | Standard Deviation | percent change | | Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge). | | | | ID | Title | Description |
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| OG000 | Pooled Placebo | Participants received a single dose of placebo IV injection after hemodialysis. | | OG001 | Etelcalcetide 5 mg | Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis. | | OG002 | Etelcalcetide 10 mg | Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis. | | OG003 | Etelcalcetide 20 mg | Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis. | | OG004 | Etelcalcetide 40 mg |
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| Secondary | Percent Change From Baseline in Serum Phosphorus | | Participants who were randomized and received any amount of study medication with available data at each time point. | Posted | | Mean | Standard Deviation | percent change | | Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge). | | | | ID | Title | Description |
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| OG000 | Pooled Placebo | Participants received a single dose of placebo IV injection after hemodialysis. | | OG001 | Etelcalcetide 5 mg | Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis. | | OG002 | Etelcalcetide 10 mg | Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis. | | OG003 | Etelcalcetide 20 mg | Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis. | | OG004 | Etelcalcetide 40 mg |
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| Secondary | Percent Change From Baseline in Calcium Phosphorus Product | | Participants who were randomized and received any amount of study medication with available data at each time point. | Posted | | Mean | Standard Deviation | percent change | | Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge). | | | | ID | Title | Description |
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| OG000 | Pooled Placebo | Participants received a single dose of placebo IV injection after hemodialysis. | | OG001 | Etelcalcetide 5 mg | Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis. | | OG002 | Etelcalcetide 10 mg | Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis. | | OG003 | Etelcalcetide 20 mg | Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis. | | OG004 | Etelcalcetide 40 mg |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide | | Participants who were randomized and received any amount of etelcalcetide. | Posted | | Mean | Standard Deviation | μg/L | | Pre-dose and at 0.17, 0.5, 1, 4, 8, 18, 24, 32, and 48 hours after study drug administration and prior to discharge from the clinical research unit (~65 hours). | | | | ID | Title | Description |
|---|
| OG000 | Etelcalcetide 5 mg | Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis. | | OG001 | Etelcalcetide 10 mg | Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis. | | OG002 | Etelcalcetide 20 mg | Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis. | | OG003 | Etelcalcetide 40 mg | Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis. | | OG004 | Etelcalcetide 60 mg |
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| Secondary | Area Under the Concentration-time Curve From Time 0 to 65 Hours Post-dose for Etelcalcetide | | Participants who were randomized and received any amount of etelcalcetide with available data. | Posted | | Mean | Standard Deviation | hr*μg/L | | Pre-dose and at 0.17, 0.5, 1, 4, 8, 18, 24, 32, and 48 hours after study drug administration and prior to discharge from the clinical research unit (~65 hours). | | | | ID | Title | Description |
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| OG000 | Etelcalcetide 5 mg | Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis. | | OG001 | Etelcalcetide 10 mg | Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis. | | OG002 | Etelcalcetide 20 mg | Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis. | | OG003 | Etelcalcetide 40 mg | Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis. | | OG004 |
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| Secondary | Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide | | Participants who were randomized and received any amount of etelcalcetide and with available data; The half-life associated with the terminal (log-linear) elimination phase values for the 40 mg dose level were not calculated due to poor log linear regression of the log concentration versus time profile during the terminal phase (r2 values <0.7). | Posted | | Mean | Standard Deviation | hr*μg/L | | Pre-dose and at 0.17, 0.5, 1, 4, 8, 18, 24, 32, and 48 hours after study drug administration and prior to discharge from the clinical research unit (~65 hours). | | | | ID | Title | Description |
|---|
| OG000 | Etelcalcetide 5 mg | Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis. | | OG001 | Etelcalcetide 10 mg | Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis. | | OG002 | Etelcalcetide 20 mg | Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis. | | OG003 | Etelcalcetide 40 mg |
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| Secondary | Percent AUC Extrapolated to Infinity (AUCINF) Resulting From Extrapolation From 65 Hours Onward for Etelcalcetide | | Participants who were randomized and received any amount of etelcalcetide and with available data. | Posted | | Mean | Standard Deviation | percentage of AUCINF | | Pre-dose and at 0.17, 0.5, 1, 4, 8, 18, 24, 32, and 48 hours after study drug administration and prior to discharge from the clinical research unit (~65 hours). | | | | ID | Title | Description |
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| OG000 | Etelcalcetide 5 mg | Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis. | | OG001 | Etelcalcetide 10 mg | Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis. | | OG002 | Etelcalcetide 20 mg | Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis. | | OG003 | Etelcalcetide 40 mg | Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis. | |
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