Hyperparathyroidism, Secondary
Conditions
Keywords
Clinical Trial, Phase 1, Renal Dialysis, Secondary Hyperparathyroidism, Parathyroid hormone
Brief summary
The purpose of this study is to characterize the safety and tolerability of single rising doses of etelcalcetide in hemodialysis patients with secondary hyperparathyroidism.
Interventions
DRUGPlacebo
Single IV injection.
DRUGEtelcalcetide
Single IV injection. The initial dose was 5 mg and dose escalation proceeded with subsequent doses of 10 mg, 20 mg, 40 mg and 60 mg.
Sponsors
KAI Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects provides written informed consent. * Intact parathyroid hormone (iPTH) ≥ 400 pg/mL (≥ 300 and \< 1200 pg/ml for Cohorts 1-3). * Serum corrected calcium ≥ 9.0 mg/dL * Receiving hemodialysis three times per week for at least 3 months and had adequate hemodialysis with a delivered Kt/V (dialyzer clearance of urea \* dialysis time/ volume of distribution of urea) ≥ 1.2 or urea reduction ratio (URR) ≥ 65%. * Excepting chronic renal failure, subject is judged to be in stable medical condition based on medical history, physical examination, and routine laboratory tests
Exclusion criteria
* History or symptomatic ventricular dysrhythmias * History of angina pectoris or congestive heart failure * History of myocardial infarction, coronary angioplasty, or coronary artery bypass grafting within the past 6 months * History of or treatment for seizure disorder * Recent (3 months) parathyroidectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Percent Change From Baseline in Serum Corrected Calcium | 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 |
| Percent Change From Baseline in Ionized Calcium | Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge). |
| Percent Change From Baseline in Serum Phosphorus | Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge). |
| Percent Change From Baseline in Calcium Phosphorus Product | Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge). |
| Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 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 |
| Area Under the Concentration-time Curve From Time 0 to 65 Hours Post-dose for Etelcalcetide | 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). |
| Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide | 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). |
| Percent AUC Extrapolated to Infinity (AUCINF) Resulting From Extrapolation From 65 Hours Onward for Etelcalcetide | 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). |
| Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide | 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). |
Countries
Australia, United States
Participant flow
Recruitment details
This study was conducted at 1 center in Australia and 2 centers in the United States from 07 September 2010 to 02 April 2011.
Pre-assignment details
Cohorts 1-3 were conducted with a two-period crossover design. Each cohort enrolled four participants randomized 1:1 to etelcalcetide followed by placebo or placebo followed by etelcalcetide. Cohorts 4 and 5 followed a parallel group design. Within each cohort eight participants were randomized 1:1 to receive placebo or etelcalcetide.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: Placebo/Etelcalcetide 5 mg Participants in Cohort 1 received single doses of 5 mg etelcalcetide and placebo in a crossover design, 7-14 days apart | 4 |
| Cohort 2: Placebo/Etelcalcetide 10 mg Participants in Cohort 2 received single doses of 10 mg etelcalcetide and placebo in a crossover design, 7-14 days apart | 4 |
| Cohort 3: Placebo/Etelcalcetide 20 mg Participants in Cohort 3 received single doses of 20 mg etelcalcetide and placebo in a crossover design, 7-14 days apart | 4 |
| Cohort 4: Placebo/Etelcalcetide 40 mg Participants in Cohort 4 received a single dose of 40 mg etelcalcetide or placebo in a parallel group design. | 8 |
| Cohort 5: Placebo/Etelcalcetide 60 mg Participants in Cohort 5 received a single dose of 60 mg etelcalcetide or placebo in a parallel group design. | 8 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Cohort 1: Placebo/Etelcalcetide 5 mg | Cohort 2: Placebo/Etelcalcetide 10 mg | Cohort 3: Placebo/Etelcalcetide 20 mg | Cohort 4: Placebo/Etelcalcetide 40 mg | Cohort 5: Placebo/Etelcalcetide 60 mg | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 54.3 years STANDARD_DEVIATION 10.4 | 59.0 years STANDARD_DEVIATION 14.5 | 52.8 years STANDARD_DEVIATION 21.2 | 52.9 years STANDARD_DEVIATION 14.6 | 47.5 years STANDARD_DEVIATION 10.9 | 52.4 years STANDARD_DEVIATION 13.6 |
| Ethnicity Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity Non-Hispanic or Latino | 4 Participants | 4 Participants | 4 Participants | 8 Participants | 8 Participants | 28 Participants |
| Race African American | 2 Participants | 4 Participants | 3 Participants | 8 Participants | 7 Participants | 24 Participants |
| Race Asian | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race White | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants | 4 Participants | 2 Participants | 8 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 3 Participants | 4 Participants | 6 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 20 | 1 / 4 | 1 / 3 | 1 / 4 | 4 / 4 | 2 / 4 |
| serious Total, serious adverse events | 1 / 20 | 0 / 4 | 0 / 3 | 0 / 4 | 0 / 4 | 0 / 4 |
Outcome results
Primary
Number of Participants With Adverse Events
Time frame: 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.
Population: All participants who were randomized and received any amount of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pooled Placebo | Number of Participants With Adverse Events | Deaths due to adverse events | 0 participants |
| Pooled Placebo | Number of Participants With Adverse Events | Serious adverse events | 1 participants |
| Pooled Placebo | Number of Participants With Adverse Events | Any adverse events | 2 participants |
| Pooled Placebo | Number of Participants With Adverse Events | Treatment-related adverse events | 1 participants |
| Pooled Placebo | Number of Participants With Adverse Events | Withdrawal due to adverse events | 1 participants |
| Etelcalcetide 5 mg | Number of Participants With Adverse Events | Serious adverse events | 0 participants |
| Etelcalcetide 5 mg | Number of Participants With Adverse Events | Deaths due to adverse events | 0 participants |
| Etelcalcetide 5 mg | Number of Participants With Adverse Events | Any adverse events | 1 participants |
| Etelcalcetide 5 mg | Number of Participants With Adverse Events | Treatment-related adverse events | 1 participants |
| Etelcalcetide 5 mg | Number of Participants With Adverse Events | Withdrawal due to adverse events | 0 participants |
| Etelcalcetide 10 mg | Number of Participants With Adverse Events | Serious adverse events | 0 participants |
| Etelcalcetide 10 mg | Number of Participants With Adverse Events | Deaths due to adverse events | 0 participants |
| Etelcalcetide 10 mg | Number of Participants With Adverse Events | Treatment-related adverse events | 1 participants |
| Etelcalcetide 10 mg | Number of Participants With Adverse Events | Withdrawal due to adverse events | 0 participants |
| Etelcalcetide 10 mg | Number of Participants With Adverse Events | Any adverse events | 1 participants |
| Etelcalcetide 20 mg | Number of Participants With Adverse Events | Withdrawal due to adverse events | 0 participants |
| Etelcalcetide 20 mg | Number of Participants With Adverse Events | Any adverse events | 1 participants |
| Etelcalcetide 20 mg | Number of Participants With Adverse Events | Serious adverse events | 0 participants |
| Etelcalcetide 20 mg | Number of Participants With Adverse Events | Deaths due to adverse events | 0 participants |
| Etelcalcetide 20 mg | Number of Participants With Adverse Events | Treatment-related adverse events | 0 participants |
| Etelcalcetide 40 mg | Number of Participants With Adverse Events | Deaths due to adverse events | 0 participants |
| Etelcalcetide 40 mg | Number of Participants With Adverse Events | Any adverse events | 4 participants |
| Etelcalcetide 40 mg | Number of Participants With Adverse Events | Treatment-related adverse events | 4 participants |
| Etelcalcetide 40 mg | Number of Participants With Adverse Events | Serious adverse events | 0 participants |
| Etelcalcetide 40 mg | Number of Participants With Adverse Events | Withdrawal due to adverse events | 0 participants |
| Etelcalcetide 60 mg | Number of Participants With Adverse Events | Any adverse events | 2 participants |
| Etelcalcetide 60 mg | Number of Participants With Adverse Events | Deaths due to adverse events | 0 participants |
| Etelcalcetide 60 mg | Number of Participants With Adverse Events | Serious adverse events | 0 participants |
| Etelcalcetide 60 mg | Number of Participants With Adverse Events | Treatment-related adverse events | 2 participants |
| Etelcalcetide 60 mg | Number of Participants With Adverse Events | Withdrawal due to adverse events | 0 participants |
Secondary
Area Under the Concentration-time Curve From Time 0 to 65 Hours Post-dose for Etelcalcetide
Time frame: 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).
Population: Participants who were randomized and received any amount of etelcalcetide with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pooled Placebo | Area Under the Concentration-time Curve From Time 0 to 65 Hours Post-dose for Etelcalcetide | 1110 hr*μg/L | Standard Deviation 182 |
| Etelcalcetide 5 mg | Area Under the Concentration-time Curve From Time 0 to 65 Hours Post-dose for Etelcalcetide | 2820 hr*μg/L | Standard Deviation 458 |
| Etelcalcetide 10 mg | Area Under the Concentration-time Curve From Time 0 to 65 Hours Post-dose for Etelcalcetide | 4920 hr*μg/L | Standard Deviation 1650 |
| Etelcalcetide 20 mg | Area Under the Concentration-time Curve From Time 0 to 65 Hours Post-dose for Etelcalcetide | 9560 hr*μg/L | Standard Deviation 3340 |
| Etelcalcetide 40 mg | Area Under the Concentration-time Curve From Time 0 to 65 Hours Post-dose for Etelcalcetide | 15700 hr*μg/L | Standard Deviation 5100 |
Secondary
Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide
Time frame: 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).
Population: Participants who were randomized and received any amount of etelcalcetide.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pooled Placebo | Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide | 145 μg/L | Standard Deviation 64.8 |
| Etelcalcetide 5 mg | Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide | 263 μg/L | Standard Deviation 67.2 |
| Etelcalcetide 10 mg | Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide | 511 μg/L | Standard Deviation 230 |
| Etelcalcetide 20 mg | Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide | 726 μg/L | Standard Deviation 278 |
| Etelcalcetide 40 mg | Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide | 1140 μg/L | Standard Deviation 428 |
Secondary
Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide
Time frame: 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).
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pooled Placebo | Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide | 3180 hr*μg/L | Standard Deviation 1350 |
| Etelcalcetide 5 mg | Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide | 5280 hr*μg/L | Standard Deviation 970 |
| Etelcalcetide 10 mg | Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide | 16800 hr*μg/L | Standard Deviation 4560 |
| Etelcalcetide 40 mg | Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide | 43800 hr*μg/L | Standard Deviation 16900 |
Secondary
Percent AUC Extrapolated to Infinity (AUCINF) Resulting From Extrapolation From 65 Hours Onward for Etelcalcetide
Time frame: 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).
Population: Participants who were randomized and received any amount of etelcalcetide and with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pooled Placebo | Percent AUC Extrapolated to Infinity (AUCINF) Resulting From Extrapolation From 65 Hours Onward for Etelcalcetide | 64.6 percentage of AUCINF | Standard Deviation 11.4 |
| Etelcalcetide 5 mg | Percent AUC Extrapolated to Infinity (AUCINF) Resulting From Extrapolation From 65 Hours Onward for Etelcalcetide | 50.9 percentage of AUCINF | Standard Deviation 9.55 |
| Etelcalcetide 10 mg | Percent AUC Extrapolated to Infinity (AUCINF) Resulting From Extrapolation From 65 Hours Onward for Etelcalcetide | 71.7 percentage of AUCINF | Standard Deviation 5.96 |
| Etelcalcetide 20 mg | Percent AUC Extrapolated to Infinity (AUCINF) Resulting From Extrapolation From 65 Hours Onward for Etelcalcetide | 60.2 percentage of AUCINF | Standard Deviation 25.8 |
| Etelcalcetide 40 mg | Percent AUC Extrapolated to Infinity (AUCINF) Resulting From Extrapolation From 65 Hours Onward for Etelcalcetide | 68.0 percentage of AUCINF | Standard Deviation 8.24 |
Secondary
Percent Change From Baseline in Calcium Phosphorus Product
Time frame: Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge).
Population: Participants who were randomized and received any amount of study medication with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | Percent Change From Baseline in Calcium Phosphorus Product | 32 Hours | 87.730 percent change | Standard Deviation 51.888 |
| Pooled Placebo | Percent Change From Baseline in Calcium Phosphorus Product | 18 Hours | 75.585 percent change | Standard Deviation 43.897 |
| Pooled Placebo | Percent Change From Baseline in Calcium Phosphorus Product | Day 4-Discharge | 86.989 percent change | Standard Deviation 50.373 |
| Pooled Placebo | Percent Change From Baseline in Calcium Phosphorus Product | 48 Hours | 86.563 percent change | Standard Deviation 54.601 |
| Pooled Placebo | Percent Change From Baseline in Calcium Phosphorus Product | 24 Hours | 77.196 percent change | Standard Deviation 51.499 |
| Pooled Placebo | Percent Change From Baseline in Calcium Phosphorus Product | 1 Hour | 10.828 percent change | Standard Deviation 14.55 |
| Pooled Placebo | Percent Change From Baseline in Calcium Phosphorus Product | 30 Minutes | 6.658 percent change | Standard Deviation 13.202 |
| Pooled Placebo | Percent Change From Baseline in Calcium Phosphorus Product | 4 Hours | 34.681 percent change | Standard Deviation 17.635 |
| Pooled Placebo | Percent Change From Baseline in Calcium Phosphorus Product | 8 Hours | 53.138 percent change | Standard Deviation 26.86 |
| Pooled Placebo | Percent Change From Baseline in Calcium Phosphorus Product | 42 Hours | 88.570 percent change | Standard Deviation 48.114 |
| Pooled Placebo | Percent Change From Baseline in Calcium Phosphorus Product | 56 Hours | 88.531 percent change | Standard Deviation 59.1 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Calcium Phosphorus Product | 56 Hours | 93.793 percent change | Standard Deviation 59.933 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Calcium Phosphorus Product | 32 Hours | 62.691 percent change | Standard Deviation 32.631 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Calcium Phosphorus Product | 8 Hours | 31.981 percent change | Standard Deviation 22.948 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Calcium Phosphorus Product | 18 Hours | 57.263 percent change | Standard Deviation 23.373 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Calcium Phosphorus Product | 4 Hours | 29.766 percent change | Standard Deviation 10.97 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Calcium Phosphorus Product | Day 4-Discharge | 73.284 percent change | Standard Deviation 46.188 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Calcium Phosphorus Product | 48 Hours | 60.665 percent change | Standard Deviation 40.658 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Calcium Phosphorus Product | 42 Hours | 62.568 percent change | Standard Deviation 28.246 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Calcium Phosphorus Product | 30 Minutes | 2.064 percent change | Standard Deviation 2.42 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Calcium Phosphorus Product | 24 Hours | 50.020 percent change | Standard Deviation 23.032 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Calcium Phosphorus Product | 1 Hour | 8.996 percent change | Standard Deviation 4.743 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Calcium Phosphorus Product | 24 Hours | -9.383 percent change | Standard Deviation 7.93 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Calcium Phosphorus Product | 42 Hours | 5.055 percent change | Standard Deviation 11.224 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Calcium Phosphorus Product | 32 Hours | 2.355 percent change | Standard Deviation 8.476 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Calcium Phosphorus Product | 1 Hour | -2.861 percent change | Standard Deviation 16.546 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Calcium Phosphorus Product | 30 Minutes | -2.929 percent change | Standard Deviation 14.665 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Calcium Phosphorus Product | 4 Hours | 6.392 percent change | Standard Deviation 6.138 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Calcium Phosphorus Product | 56 Hours | 5.483 percent change | Standard Deviation 15.538 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Calcium Phosphorus Product | 8 Hours | -2.240 percent change | Standard Deviation 9.168 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Calcium Phosphorus Product | Day 4-Discharge | 13.653 percent change | Standard Deviation 8.448 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Calcium Phosphorus Product | 48 Hours | 0.863 percent change | Standard Deviation 10.875 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Calcium Phosphorus Product | 18 Hours | 0.424 percent change | Standard Deviation 6.565 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Calcium Phosphorus Product | 56 Hours | 23.351 percent change | Standard Deviation 25.107 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Calcium Phosphorus Product | 30 Minutes | 2.755 percent change | Standard Deviation 1.384 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Calcium Phosphorus Product | 1 Hour | 9.236 percent change | Standard Deviation 4.347 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Calcium Phosphorus Product | 4 Hours | 21.940 percent change | Standard Deviation 13.151 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Calcium Phosphorus Product | 8 Hours | 17.850 percent change | Standard Deviation 11.838 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Calcium Phosphorus Product | 18 Hours | 17.405 percent change | Standard Deviation 17.156 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Calcium Phosphorus Product | 24 Hours | 17.795 percent change | Standard Deviation 29.202 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Calcium Phosphorus Product | 32 Hours | 16.331 percent change | Standard Deviation 21.671 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Calcium Phosphorus Product | 42 Hours | 19.449 percent change | Standard Deviation 29.865 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Calcium Phosphorus Product | 48 Hours | 22.253 percent change | Standard Deviation 33.958 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Calcium Phosphorus Product | Day 4-Discharge | 39.885 percent change | Standard Deviation 28.446 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Calcium Phosphorus Product | 42 Hours | 30.694 percent change | Standard Deviation 30.875 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Calcium Phosphorus Product | 4 Hours | 26.340 percent change | Standard Deviation 10.814 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Calcium Phosphorus Product | Day 4-Discharge | 46.724 percent change | Standard Deviation 26.569 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Calcium Phosphorus Product | 56 Hours | 31.825 percent change | Standard Deviation 42.108 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Calcium Phosphorus Product | 48 Hours | 32.771 percent change | Standard Deviation 35.019 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Calcium Phosphorus Product | 1 Hour | 6.825 percent change | Standard Deviation 4.17 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Calcium Phosphorus Product | 18 Hours | 24.889 percent change | Standard Deviation 24.901 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Calcium Phosphorus Product | 30 Minutes | 8.239 percent change | Standard Deviation 7.64 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Calcium Phosphorus Product | 8 Hours | 23.291 percent change | Standard Deviation 26.675 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Calcium Phosphorus Product | 32 Hours | 25.814 percent change | Standard Deviation 39.166 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Calcium Phosphorus Product | 24 Hours | 14.095 percent change | Standard Deviation 38.924 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Calcium Phosphorus Product | 24 Hours | 18.115 percent change | Standard Deviation 30.774 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Calcium Phosphorus Product | Day 4-Discharge | 36.351 percent change | Standard Deviation 30.774 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Calcium Phosphorus Product | 42 Hours | 25.046 percent change | Standard Deviation 36.401 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Calcium Phosphorus Product | 18 Hours | 19.266 percent change | Standard Deviation 24.212 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Calcium Phosphorus Product | 8 Hours | 26.854 percent change | Standard Deviation 17.662 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Calcium Phosphorus Product | 48 Hours | 39.450 percent change | Standard Deviation 37.876 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Calcium Phosphorus Product | 4 Hours | 17.068 percent change | Standard Deviation 5.053 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Calcium Phosphorus Product | 1 Hour | 12.464 percent change | Standard Deviation 12.914 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Calcium Phosphorus Product | 56 Hours | 44.582 percent change | Standard Deviation 33.182 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Calcium Phosphorus Product | 30 Minutes | 7.789 percent change | Standard Deviation 10.252 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Calcium Phosphorus Product | 32 Hours | 33.902 percent change | Standard Deviation 27.795 |
Secondary
Percent Change From Baseline in Ionized Calcium
Time frame: Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge).
Population: Participants who were randomized and received any amount of study medication with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | Percent Change From Baseline in Ionized Calcium | 56 Hours | 5.991 percent change | Standard Deviation 7.704 |
| Pooled Placebo | Percent Change From Baseline in Ionized Calcium | 18 Hours | 6.570 percent change | Standard Deviation 5.729 |
| Pooled Placebo | Percent Change From Baseline in Ionized Calcium | 42 Hours | 8.157 percent change | Standard Deviation 8.08 |
| Pooled Placebo | Percent Change From Baseline in Ionized Calcium | 48 Hours | 6.080 percent change | Standard Deviation 8.323 |
| Pooled Placebo | Percent Change From Baseline in Ionized Calcium | Day 4-Discharge | 6.152 percent change | Standard Deviation 8.162 |
| Pooled Placebo | Percent Change From Baseline in Ionized Calcium | 24 Hours | 6.920 percent change | Standard Deviation 6.835 |
| Pooled Placebo | Percent Change From Baseline in Ionized Calcium | 30 Minutes | -0.118 percent change | Standard Deviation 2.92 |
| Pooled Placebo | Percent Change From Baseline in Ionized Calcium | 4 Hours | 0.744 percent change | Standard Deviation 3.126 |
| Pooled Placebo | Percent Change From Baseline in Ionized Calcium | 32 Hours | 5.925 percent change | Standard Deviation 7.251 |
| Pooled Placebo | Percent Change From Baseline in Ionized Calcium | 8 Hours | 1.924 percent change | Standard Deviation 4.128 |
| Pooled Placebo | Percent Change From Baseline in Ionized Calcium | 1 Hour | -0.151 percent change | Standard Deviation 2.577 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Ionized Calcium | 56 Hours | 0.612 percent change | Standard Deviation 5.53 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Ionized Calcium | 42 Hours | -0.456 percent change | Standard Deviation 3.392 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Ionized Calcium | 1 Hour | -1.406 percent change | Standard Deviation 3.173 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Ionized Calcium | 48 Hours | -1.376 percent change | Standard Deviation 4.136 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Ionized Calcium | 18 Hours | -2.168 percent change | Standard Deviation 4.508 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Ionized Calcium | 4 Hours | -3.436 percent change | Standard Deviation 4.124 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Ionized Calcium | Day 4-Discharge | 2.765 percent change | Standard Deviation 4.557 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Ionized Calcium | 8 Hours | -0.703 percent change | Standard Deviation 4.896 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Ionized Calcium | 30 Minutes | 0.234 percent change | Standard Deviation 2.172 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Ionized Calcium | 32 Hours | 0.918 percent change | Standard Deviation 3.431 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Ionized Calcium | 24 Hours | -0.663 percent change | Standard Deviation 3.64 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Ionized Calcium | 56 Hours | -3.780 percent change | Standard Deviation 4.981 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Ionized Calcium | 32 Hours | -2.830 percent change | Standard Deviation 5.873 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Ionized Calcium | 1 Hour | -1.394 percent change | Standard Deviation 3.841 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Ionized Calcium | 30 Minutes | -2.940 percent change | Standard Deviation 4.619 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Ionized Calcium | 4 Hours | -6.015 percent change | Standard Deviation 1.847 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Ionized Calcium | 24 Hours | -3.822 percent change | Standard Deviation 3.953 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Ionized Calcium | 8 Hours | -6.218 percent change | Standard Deviation 2.395 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Ionized Calcium | Day 4-Discharge | -1.697 percent change | Standard Deviation 4.582 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Ionized Calcium | 48 Hours | -2.919 percent change | Standard Deviation 3.392 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Ionized Calcium | 18 Hours | -4.125 percent change | Standard Deviation 3.667 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Ionized Calcium | 42 Hours | -4.213 percent change | Standard Deviation 1.195 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Ionized Calcium | 56 Hours | -3.766 percent change | Standard Deviation 9.005 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Ionized Calcium | 30 Minutes | -0.122 percent change | Standard Deviation 2.4 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Ionized Calcium | 1 Hour | -0.442 percent change | Standard Deviation 4.233 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Ionized Calcium | 4 Hours | -3.550 percent change | Standard Deviation 4.054 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Ionized Calcium | 8 Hours | -7.160 percent change | Standard Deviation 6.947 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Ionized Calcium | 18 Hours | -6.571 percent change | Standard Deviation 5.425 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Ionized Calcium | 24 Hours | -7.093 percent change | Standard Deviation 8.308 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Ionized Calcium | 32 Hours | -4.044 percent change | Standard Deviation 11.718 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Ionized Calcium | 42 Hours | -5.980 percent change | Standard Deviation 8.479 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Ionized Calcium | 48 Hours | -5.282 percent change | Standard Deviation 9.031 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Ionized Calcium | Day 4-Discharge | -1.174 percent change | Standard Deviation 9.134 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Ionized Calcium | 18 Hours | -3.949 percent change | Standard Deviation 5.644 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Ionized Calcium | 4 Hours | -3.759 percent change | Standard Deviation 11.275 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Ionized Calcium | Day 4-Discharge | 1.601 percent change | Standard Deviation 12.279 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Ionized Calcium | 56 Hours | -3.052 percent change | Standard Deviation 8.958 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Ionized Calcium | 48 Hours | -2.468 percent change | Standard Deviation 9.489 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Ionized Calcium | 1 Hour | -3.072 percent change | Standard Deviation 7.85 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Ionized Calcium | 42 Hours | -3.212 percent change | Standard Deviation 6.593 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Ionized Calcium | 30 Minutes | -0.934 percent change | Standard Deviation 2.007 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Ionized Calcium | 32 Hours | -5.090 percent change | Standard Deviation 10.317 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Ionized Calcium | 8 Hours | -3.867 percent change | Standard Deviation 10.572 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Ionized Calcium | 24 Hours | -5.395 percent change | Standard Deviation 11.404 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Ionized Calcium | 24 Hours | -10.916 percent change | Standard Deviation 4.793 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Ionized Calcium | 18 Hours | -12.139 percent change | Standard Deviation 5.122 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Ionized Calcium | Day 4-Discharge | -12.798 percent change | Standard Deviation 3.424 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Ionized Calcium | 42 Hours | -12.00 percent change | Standard Deviation 3.337 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Ionized Calcium | 8 Hours | -8.652 percent change | Standard Deviation 3.231 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Ionized Calcium | 48 Hours | -13.449 percent change | Standard Deviation 3.961 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Ionized Calcium | 4 Hours | -1.514 percent change | Standard Deviation 3.049 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Ionized Calcium | 1 Hour | 1.595 percent change | Standard Deviation 1.118 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Ionized Calcium | 56 Hours | -11.229 percent change | Standard Deviation 4.218 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Ionized Calcium | 30 Minutes | -3.300 percent change | Standard Deviation 5.716 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Ionized Calcium | 32 Hours | -7.627 percent change | Standard Deviation 2.563 |
Secondary
Percent Change From Baseline in Serum Corrected Calcium
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | Percent Change From Baseline in Serum Corrected Calcium | 56 Hours | 1.920 percent change | Standard Deviation 10.339 |
| Pooled Placebo | Percent Change From Baseline in Serum Corrected Calcium | 24 Hours | 3.853 percent change | Standard Deviation 8.667 |
| Pooled Placebo | Percent Change From Baseline in Serum Corrected Calcium | Day 8 | 0.632 percent change | Standard Deviation 10.506 |
| Pooled Placebo | Percent Change From Baseline in Serum Corrected Calcium | Day 15 | 3.827 percent change | Standard Deviation 8.196 |
| Pooled Placebo | Percent Change From Baseline in Serum Corrected Calcium | 48 Hours | 2.918 percent change | Standard Deviation 8.965 |
| Pooled Placebo | Percent Change From Baseline in Serum Corrected Calcium | 32 Hours | 3.079 percent change | Standard Deviation 9.187 |
| Pooled Placebo | Percent Change From Baseline in Serum Corrected Calcium | 4 Hours | 0.540 percent change | Standard Deviation 4.998 |
| Pooled Placebo | Percent Change From Baseline in Serum Corrected Calcium | 1 Hour | -0.295 percent change | Standard Deviation 4.644 |
| Pooled Placebo | Percent Change From Baseline in Serum Corrected Calcium | Day 4-Discharge | 1.556 percent change | Standard Deviation 10.24 |
| Pooled Placebo | Percent Change From Baseline in Serum Corrected Calcium | 42 Hours | 3.209 percent change | Standard Deviation 9.716 |
| Pooled Placebo | Percent Change From Baseline in Serum Corrected Calcium | 8 Hours | 0.945 percent change | Standard Deviation 5.894 |
| Pooled Placebo | Percent Change From Baseline in Serum Corrected Calcium | 18 Hours | 3.669 percent change | Standard Deviation 7.885 |
| Pooled Placebo | Percent Change From Baseline in Serum Corrected Calcium | Day 29 | 4.228 percent change | Standard Deviation 9.346 |
| Pooled Placebo | Percent Change From Baseline in Serum Corrected Calcium | 30 Minutes | 0.024 percent change | Standard Deviation 3.881 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Corrected Calcium | 18 Hours | -3.103 percent change | Standard Deviation 3.399 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Corrected Calcium | 32 Hours | -1.632 percent change | Standard Deviation 7.315 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Corrected Calcium | 56 Hours | -1.583 percent change | Standard Deviation 4.258 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Corrected Calcium | 4 Hours | -3.427 percent change | Standard Deviation 1.201 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Corrected Calcium | 48 Hours | -2.781 percent change | Standard Deviation 7.855 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Corrected Calcium | 8 Hours | -5.533 percent change | Standard Deviation 8.724 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Corrected Calcium | 24 Hours | -3.003 percent change | Standard Deviation 4.149 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Corrected Calcium | 42 Hours | -4.815 percent change | Standard Deviation 8.629 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Corrected Calcium | Day 4-Discharge | -2.577 percent change | Standard Deviation 12.131 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Corrected Calcium | 1 Hour | 0.256 percent change | Standard Deviation 1.043 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Corrected Calcium | 30 Minutes | 0.106 percent change | Standard Deviation 4.55 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Corrected Calcium | 56 Hours | -10.338 percent change | Standard Deviation 4.119 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Corrected Calcium | 32 Hours | -9.436 percent change | Standard Deviation 2.192 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Corrected Calcium | 1 Hour | -5.176 percent change | Standard Deviation 2.874 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Corrected Calcium | Day 4-Discharge | -7.405 percent change | Standard Deviation 4.208 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Corrected Calcium | 4 Hours | -7.795 percent change | Standard Deviation 2.473 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Corrected Calcium | 30 Minutes | -2.883 percent change | Standard Deviation 2.457 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Corrected Calcium | 42 Hours | -9.049 percent change | Standard Deviation 3.745 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Corrected Calcium | 8 Hours | -10.697 percent change | Standard Deviation 4.257 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Corrected Calcium | 18 Hours | -8.018 percent change | Standard Deviation 6.15 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Corrected Calcium | 48 Hours | -9.115 percent change | Standard Deviation 0.28 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Corrected Calcium | 24 Hours | -8.826 percent change | Standard Deviation 2.766 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Serum Corrected Calcium | 1 Hour | -2.574 percent change | Standard Deviation 1.335 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Serum Corrected Calcium | 30 Minutes | -2.589 percent change | Standard Deviation 1.665 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Serum Corrected Calcium | 4 Hours | -5.515 percent change | Standard Deviation 1.939 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Serum Corrected Calcium | 8 Hours | -7.685 percent change | Standard Deviation 2.633 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Serum Corrected Calcium | 18 Hours | -9.560 percent change | Standard Deviation 4.703 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Serum Corrected Calcium | 24 Hours | -11.436 percent change | Standard Deviation 5.463 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Serum Corrected Calcium | 32 Hours | -10.644 percent change | Standard Deviation 8.525 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Serum Corrected Calcium | 42 Hours | -11.700 percent change | Standard Deviation 8.151 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Serum Corrected Calcium | 48 Hours | -9.458 percent change | Standard Deviation 7.873 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Serum Corrected Calcium | 56 Hours | -9.227 percent change | Standard Deviation 6.946 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Serum Corrected Calcium | Day 4-Discharge | -9.200 percent change | Standard Deviation 6.76 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Corrected Calcium | 42 Hours | -9.186 percent change | Standard Deviation 8.793 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Corrected Calcium | 24 Hours | -8.436 percent change | Standard Deviation 10.582 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Corrected Calcium | 18 Hours | -5.993 percent change | Standard Deviation 9.27 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Corrected Calcium | 30 Minutes | -0.572 percent change | Standard Deviation 2.126 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Corrected Calcium | 48 Hours | -8.174 percent change | Standard Deviation 9.005 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Corrected Calcium | 8 Hours | -5.895 percent change | Standard Deviation 5.393 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Corrected Calcium | Day 29 | 2.221 percent change | Standard Deviation 2.378 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Corrected Calcium | 56 Hours | -8.970 percent change | Standard Deviation 8.789 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Corrected Calcium | 32 Hours | -6.155 percent change | Standard Deviation 12.748 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Corrected Calcium | 4 Hours | -3.599 percent change | Standard Deviation 2.991 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Corrected Calcium | Day 4-Discharge | -8.180 percent change | Standard Deviation 9.334 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Corrected Calcium | 1 Hour | -3.700 percent change | Standard Deviation 3.395 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Corrected Calcium | Day 8 | -3.985 percent change | Standard Deviation 12.631 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Corrected Calcium | Day 15 | -0.238 percent change | Standard Deviation 8.371 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Corrected Calcium | 42 Hours | -9.082 percent change | Standard Deviation 7.392 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Corrected Calcium | 1 Hour | 3.445 percent change | Standard Deviation 9.876 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Corrected Calcium | 18 Hours | -5.738 percent change | Standard Deviation 10.402 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Corrected Calcium | Day 29 | 3.620 percent change | Standard Deviation 7.196 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Corrected Calcium | 32 Hours | -7.146 percent change | Standard Deviation 10.382 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Corrected Calcium | Day 4-Discharge | -13.186 percent change | Standard Deviation 9.781 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Corrected Calcium | 48 Hours | -10.911 percent change | Standard Deviation 9.479 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Corrected Calcium | 8 Hours | -4.057 percent change | Standard Deviation 10.732 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Corrected Calcium | 24 Hours | -5.688 percent change | Standard Deviation 9.762 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Corrected Calcium | 4 Hours | -1.258 percent change | Standard Deviation 10.241 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Corrected Calcium | Day 15 | -6.885 percent change | Standard Deviation 9.669 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Corrected Calcium | Day 8 | -8.859 percent change | Standard Deviation 3.74 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Corrected Calcium | 56 Hours | -12.300 percent change | Standard Deviation 9.491 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Corrected Calcium | 30 Minutes | 1.951 percent change | Standard Deviation 6.723 |
Secondary
Percent Change From Baseline in Serum Parathyroid Hormone (PTH)
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 30 Minutes | 1.381 percent change | Standard Deviation 20.429 |
| Pooled Placebo | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 48 Hours | -21.664 percent change | Standard Deviation 28.956 |
| Pooled Placebo | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 56 Hours | -15.484 percent change | Standard Deviation 33.626 |
| Pooled Placebo | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | Day 15 | -33.993 percent change | Standard Deviation 44.928 |
| Pooled Placebo | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 4 Hours | 3.922 percent change | Standard Deviation 30.491 |
| Pooled Placebo | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | Day 8 | -31.881 percent change | Standard Deviation 38.536 |
| Pooled Placebo | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 8 Hours | 4.014 percent change | Standard Deviation 25.061 |
| Pooled Placebo | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 18 Hours | -13.552 percent change | Standard Deviation 25 |
| Pooled Placebo | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | Day 29 | -31.394 percent change | Standard Deviation 47.249 |
| Pooled Placebo | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 24 Hours | -16.888 percent change | Standard Deviation 30.497 |
| Pooled Placebo | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 1 Hour | -0.540 percent change | Standard Deviation 17.092 |
| Pooled Placebo | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 32 Hours | -16.434 percent change | Standard Deviation 34.774 |
| Pooled Placebo | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | Day 4-Discharge | -11.192 percent change | Standard Deviation 33.131 |
| Pooled Placebo | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 42 Hours | -20.394 percent change | Standard Deviation 25.119 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 18 Hours | -23.751 percent change | Standard Deviation 10.615 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 4 Hours | -39.975 percent change | Standard Deviation 14.961 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 42 Hours | -9.087 percent change | Standard Deviation 10.439 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 24 Hours | -23.420 percent change | Standard Deviation 10.289 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 56 Hours | -2.968 percent change | Standard Deviation 20.87 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 8 Hours | -39.789 percent change | Standard Deviation 9.694 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 32 Hours | -18.406 percent change | Standard Deviation 15.484 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | Day 4-Discharge | -7.428 percent change | Standard Deviation 15.016 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 30 Minutes | -63.179 percent change | Standard Deviation 5.135 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 48 Hours | -14.905 percent change | Standard Deviation 16.588 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 1 Hour | -64.094 percent change | Standard Deviation 4.547 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 4 Hours | -51.734 percent change | Standard Deviation 23.294 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 32 Hours | -32.987 percent change | Standard Deviation 26.492 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 8 Hours | -52.075 percent change | Standard Deviation 16.841 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 18 Hours | -48.744 percent change | Standard Deviation 15.46 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | Day 4-Discharge | 13.264 percent change | Standard Deviation 23.682 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 24 Hours | -46.642 percent change | Standard Deviation 18.136 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 48 Hours | -36.142 percent change | Standard Deviation 24.957 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 1 Hour | -73.060 percent change | Standard Deviation 7.959 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 56 Hours | -21.994 percent change | Standard Deviation 34.015 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 30 Minutes | -68.890 percent change | Standard Deviation 9.616 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 42 Hours | -34.912 percent change | Standard Deviation 22.835 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 1 Hour | -70.309 percent change | Standard Deviation 9.601 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 48 Hours | -43.145 percent change | Standard Deviation 43.175 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 30 Minutes | -70.021 percent change | Standard Deviation 11.273 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 4 Hours | -72.893 percent change | Standard Deviation 14.821 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 8 Hours | -70.904 percent change | Standard Deviation 15.663 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 56 Hours | -43.271 percent change | Standard Deviation 44.442 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 42 Hours | -57.207 percent change | Standard Deviation 32.894 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 32 Hours | -55.919 percent change | Standard Deviation 33.153 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 24 Hours | -41.723 percent change | Standard Deviation 26.353 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 18 Hours | -72.653 percent change | Standard Deviation 16.154 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | Day 4-Discharge | -48.533 percent change | Standard Deviation 32.739 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 42 Hours | -63.258 percent change | Standard Deviation 5.239 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 30 Minutes | -72.435 percent change | Standard Deviation 11.176 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 1 Hour | -75.898 percent change | Standard Deviation 11.333 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 4 Hours | -74.627 percent change | Standard Deviation 13.479 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 8 Hours | -77.031 percent change | Standard Deviation 8.236 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 18 Hours | -78.332 percent change | Standard Deviation 7.393 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 24 Hours | -77.206 percent change | Standard Deviation 4.005 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 32 Hours | -69.795 percent change | Standard Deviation 4.812 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 48 Hours | -55.486 percent change | Standard Deviation 1.761 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 56 Hours | -48.128 percent change | Standard Deviation 3.74 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | Day 4-Discharge | -49.277 percent change | Standard Deviation 6.274 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | Day 8 | -30.766 percent change | Standard Deviation 32.248 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | Day 15 | -34.149 percent change | Standard Deviation 22.536 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | Day 29 | -14.750 percent change | Standard Deviation 28.303 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 24 Hours | -84.845 percent change | Standard Deviation 6.208 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 18 Hours | -85.547 percent change | Standard Deviation 6.056 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 8 Hours | -84.184 percent change | Standard Deviation 6.461 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | Day 15 | -58.510 percent change | Standard Deviation 15.169 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | Day 4-Discharge | -62.628 percent change | Standard Deviation 12.335 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 4 Hours | -80.266 percent change | Standard Deviation 7.476 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 30 Minutes | -77.471 percent change | Standard Deviation 5.979 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | Day 8 | -61.093 percent change | Standard Deviation 5.804 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 1 Hour | -78.757 percent change | Standard Deviation 4.921 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 48 Hours | -71.268 percent change | Standard Deviation 11.557 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 42 Hours | -76.096 percent change | Standard Deviation 9.079 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | Day 29 | -44.478 percent change | Standard Deviation 16.631 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 56 Hours | -60.112 percent change | Standard Deviation 16.074 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Parathyroid Hormone (PTH) | 32 Hours | -83.439 percent change | Standard Deviation 5.802 |
Secondary
Percent Change From Baseline in Serum Phosphorus
Time frame: Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge).
Population: Participants who were randomized and received any amount of study medication with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | Percent Change From Baseline in Serum Phosphorus | 48 Hours | 80.245 percent change | Standard Deviation 48.363 |
| Pooled Placebo | Percent Change From Baseline in Serum Phosphorus | 30 Minutes | 6.453 percent change | Standard Deviation 10.4 |
| Pooled Placebo | Percent Change From Baseline in Serum Phosphorus | 1 Hour | 10.907 percent change | Standard Deviation 10.912 |
| Pooled Placebo | Percent Change From Baseline in Serum Phosphorus | Day 4-Discharge | 83.535 percent change | Standard Deviation 44.193 |
| Pooled Placebo | Percent Change From Baseline in Serum Phosphorus | 8 Hours | 51.998 percent change | Standard Deviation 27.762 |
| Pooled Placebo | Percent Change From Baseline in Serum Phosphorus | 32 Hours | 81.616 percent change | Standard Deviation 48.245 |
| Pooled Placebo | Percent Change From Baseline in Serum Phosphorus | 4 Hours | 34.009 percent change | Standard Deviation 16.904 |
| Pooled Placebo | Percent Change From Baseline in Serum Phosphorus | 42 Hours | 82.478 percent change | Standard Deviation 44.276 |
| Pooled Placebo | Percent Change From Baseline in Serum Phosphorus | 56 Hours | 83.741 percent change | Standard Deviation 51.885 |
| Pooled Placebo | Percent Change From Baseline in Serum Phosphorus | 18 Hours | 69.207 percent change | Standard Deviation 41.794 |
| Pooled Placebo | Percent Change From Baseline in Serum Phosphorus | 24 Hours | 69.676 percent change | Standard Deviation 45.038 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Phosphorus | 4 Hours | 34.441 percent change | Standard Deviation 12.211 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Phosphorus | 42 Hours | 72.340 percent change | Standard Deviation 35.38 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Phosphorus | 8 Hours | 41.575 percent change | Standard Deviation 33.433 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Phosphorus | 56 Hours | 98.775 percent change | Standard Deviation 67.669 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Phosphorus | 32 Hours | 67.662 percent change | Standard Deviation 43.365 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Phosphorus | Day 4-Discharge | 78.775 percent change | Standard Deviation 45.141 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Phosphorus | 48 Hours | 66.536 percent change | Standard Deviation 45.455 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Phosphorus | 30 Minutes | 2.080 percent change | Standard Deviation 4.235 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Phosphorus | 24 Hours | 55.497 percent change | Standard Deviation 29.444 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Phosphorus | 1 Hour | 8.750 percent change | Standard Deviation 5.519 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Phosphorus | 18 Hours | 62.681 percent change | Standard Deviation 26.476 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Phosphorus | 30 Minutes | -0.255 percent change | Standard Deviation 12.843 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Phosphorus | 48 Hours | 10.970 percent change | Standard Deviation 11.808 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Phosphorus | 18 Hours | 9.206 percent change | Standard Deviation 2.538 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Phosphorus | 56 Hours | 17.867 percent change | Standard Deviation 18.308 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Phosphorus | 8 Hours | 9.325 percent change | Standard Deviation 5.563 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Phosphorus | 4 Hours | 15.334 percent change | Standard Deviation 4.08 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Phosphorus | 1 Hour | 2.219 percent change | Standard Deviation 15.246 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Phosphorus | Day 4-Discharge | 23.022 percent change | Standard Deviation 12.403 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Phosphorus | 24 Hours | -0.574 percent change | Standard Deviation 8.659 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Phosphorus | 32 Hours | 12.914 percent change | Standard Deviation 6.547 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Phosphorus | 42 Hours | 15.357 percent change | Standard Deviation 8.616 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Serum Phosphorus | 42 Hours | 35.259 percent change | Standard Deviation 31.535 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Serum Phosphorus | 48 Hours | 34.452 percent change | Standard Deviation 31.33 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Serum Phosphorus | 56 Hours | 35.569 percent change | Standard Deviation 21.851 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Serum Phosphorus | Day 4-Discharge | 54.242 percent change | Standard Deviation 30.386 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Serum Phosphorus | 30 Minutes | 5.498 percent change | Standard Deviation 1.546 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Serum Phosphorus | 1 Hour | 12.164 percent change | Standard Deviation 5.483 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Serum Phosphorus | 4 Hours | 29.231 percent change | Standard Deviation 15.513 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Serum Phosphorus | 8 Hours | 27.684 percent change | Standard Deviation 12.52 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Serum Phosphorus | 18 Hours | 30.352 percent change | Standard Deviation 22.143 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Serum Phosphorus | 24 Hours | 32.376 percent change | Standard Deviation 28.527 |
| Etelcalcetide 20 mg | Percent Change From Baseline in Serum Phosphorus | 32 Hours | 29.678 percent change | Standard Deviation 15.174 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Phosphorus | 48 Hours | 43.624 percent change | Standard Deviation 29.435 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Phosphorus | Day 4-Discharge | 59.563 percent change | Standard Deviation 19.668 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Phosphorus | 30 Minutes | 9.024 percent change | Standard Deviation 10.125 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Phosphorus | 56 Hours | 43.033 percent change | Standard Deviation 33.634 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Phosphorus | 42 Hours | 43.149 percent change | Standard Deviation 25.219 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Phosphorus | 32 Hours | 32.705 percent change | Standard Deviation 28.481 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Phosphorus | 18 Hours | 32.018 percent change | Standard Deviation 14.688 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Phosphorus | 1 Hour | 11.018 percent change | Standard Deviation 5.492 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Phosphorus | 24 Hours | 24.240 percent change | Standard Deviation 37.457 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Phosphorus | 8 Hours | 30.640 percent change | Standard Deviation 24.248 |
| Etelcalcetide 40 mg | Percent Change From Baseline in Serum Phosphorus | 4 Hours | 30.927 percent change | Standard Deviation 8.124 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Phosphorus | 8 Hours | 32.465 percent change | Standard Deviation 15.418 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Phosphorus | 1 Hour | 8.621 percent change | Standard Deviation 4.78 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Phosphorus | 18 Hours | 26.240 percent change | Standard Deviation 19.622 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Phosphorus | 30 Minutes | 5.608 percent change | Standard Deviation 4.474 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Phosphorus | Day 4-Discharge | 56.708 percent change | Standard Deviation 29.407 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Phosphorus | 42 Hours | 36.299 percent change | Standard Deviation 31.742 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Phosphorus | 24 Hours | 24.655 percent change | Standard Deviation 27.651 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Phosphorus | 56 Hours | 63.990 percent change | Standard Deviation 28.031 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Phosphorus | 32 Hours | 43.411 percent change | Standard Deviation 19.01 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Phosphorus | 4 Hours | 19.261 percent change | Standard Deviation 9.807 |
| Etelcalcetide 60 mg | Percent Change From Baseline in Serum Phosphorus | 48 Hours | 55.718 percent change | Standard Deviation 35.112 |