Chronic Kidney Disease, Secondary Hyperparathyroidism
Conditions
Keywords
Secondary Hyperparathyroidism, chronic kidney disease, hemodialysis
Brief summary
This is a study to evaluate the safety and pharmacokinetics in pediatric patients with secondary hyperparathyroidism receiving a single dose of etelcalcetide at the end of hemodialysis.
Interventions
DRUGEtelcalcetide
A single IV-bolus dose of 0.035 mg/kg etelcalcetide into the venous line of the dialysis circuit at the end of a hemodialysis session.
Sponsors
Amgen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Subject's parent has provided informed consent and subject has provided assent * Children Age 2 to less than 18 years * Diagnosed with chronic kidney disease * Diagnosed with secondary hyperparathyroidism receiving hemodialysis, * Weighing at least 7 kg * Laboratory results within specified range.
Exclusion criteria
* Currently receiving treatment in another investigation device or drug study * Subject has received cinacalcet therapy within 30 days * History of prolongation QT interval * Subject is taking any medications that are on the QT prolongation medication list * Electrocardiograph (ECG) measurements within specified range.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Corrected (Fridericia) QT Interval at End of Study | Baseline and day 30 (end of study) | — |
| Change From Baseline in Serum Potassium Concentration at End of Study | Baseline and day 30 (end of study) | — |
| Change From Baseline in Intact Parathyroid Hormone (iPTH) Levels Over Time | Baseline and day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study) | — |
| Change From Baseline in Heart Rate at End of Study | Baseline and day 30 (end of study) | — |
| Change From Baseline in Temperature at End of Study | Baseline and day 30 (end of study) | — |
| Change From Baseline in Blood Pressure at End of Study | Baseline and day 30 (end of study) | — |
| Change From Baseline in PR Interval at End of Study | Baseline and day 30 (end of study) | — |
| Change From Baseline in QRS Interval at End of Study | Baseline and day 30 (end of study) | — |
| Change From Baseline in QT Interval at End of Study | Baseline and day 30 (end of study) | — |
| Change From Baseline in Corrected (Bazett) QT Interval at End of Study | Baseline and day 30 (end of study) | — |
| Common Treatment-emergent Adverse Events | 30 days | A treatment-emergent adverse event is any adverse event (AE) that begins or worsens after the initial dose of study drug (etelcalcetide) and up to 30 days after the last dose. Common adverse events were defined as adverse events occurring in at least 2 participants. The Medical Dictionary for Regulatory Activities (MedDRA) version 21.0 was used for coding all adverse events. |
| Change From Baseline in Serum Corrected Calcium Concentration Over Time | Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study) | When albumin was less than 4.0 mg/dL, the calcium concentration was corrected according to the formula: cCa (mmol/L) = measured total serum calcium (mmol/L) + 0.02 (40 - serum albumin \[g/L\]). |
| Change From Baseline in Serum Phosphorus Concentration at End of Study | Baseline and day 30 (end of study) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Serum Ionized Calcium Concentration | Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study) | — |
| Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide | 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose | Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL. |
| Time to Maximum Concentration (Tmax) of Etelcalcetide | 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose | Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL. |
| Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) | 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose | Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL. Area under the curve for plasma etelcalcetide from time zero to the last quantifiable concentration (AUClast) was estimated using the linear trapezoidal method. |
| Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero Infinity (AUCinf) | 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose | Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL. Area under the concentration-time curve from time zero to infinite time (AUCinf) was estimated using the linear trapezoidal method. |
| Terminal Half-life (T1/2,z) of Etelcalcetide | 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose | Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL. Terminal half life of plasma etelcalcetide (t1/2,z) was calculated as t1/2,z = ln(2)/λz, where λz is the first-order terminal rate constant estimated by linear regression of the terminal log-linear phase. |
| Number of Participants Who Developed Anti-etelcalcetide Binding Antibodies | Baseline and day 30 | Samples were collected predose and at end of study (day 30) and tested for anti etelcalcetide binding antibodies using a validated immunoassay. Developing antibody binding was defined as participants who were binding antibody positive postbaseline with a negative result at baseline. |
| Number of Participants With Treatment-emergent Adverse Events | 30 days | A treatment-emergent adverse event is any adverse event that begins or worsens after the initial dose of study drug (etelcalcetide) and up to 30 days after the last dose. The severity of each adverse event was graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 1 = Mild (asymptomatic or mild symptoms), Grade 2 = Moderate (minimal, local or noninvasive intervention indicated), Grade 3 = Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated, Grade 4 = Life-threatening consequences; urgent intervention indicated, and Grade 5 = Death related to AE. |
| Change From Baseline in Serum Total Calcium Concentration | Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study) | — |
Countries
Belgium, Germany, Lithuania, Poland, United Kingdom, United States
Participant flow
Recruitment details
This study was conducted at 6 centers in the United States, United Kingdom, and the European Union. Participants were enrolled from 14 March 2017 to 01 October 2018.
Participants by arm
| Arm | Count |
|---|---|
| Etelcalcetide Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1. | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Etelcalcetide |
|---|---|
| Age, Continuous | 10.3 years STANDARD_DEVIATION 4.3 |
| Age, Customized Adolescents (12 to 17 years) | 6 Participants |
| Age, Customized Children (2 to 11 years) | 5 Participants |
| Blood Pressure Diastolic blood pressure | 66.7 mmHg STANDARD_DEVIATION 15.1 |
| Blood Pressure Systolic blood pressure | 119.4 mmHg STANDARD_DEVIATION 15.9 |
| Corrected (Bazett) QT Interval (QTcB) | 424.2 ms STANDARD_DEVIATION 29.1 |
| Corrected (Fridericia) QT Interval (QTcF) | 402.7 ms STANDARD_DEVIATION 26.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Heart Rate | 87.4 beats/minute STANDARD_DEVIATION 9.9 |
| PR Interval | 133.8 ms STANDARD_DEVIATION 8.7 |
| QRS Interval | 82.0 ms STANDARD_DEVIATION 10.9 |
| QT Interval | 363.5 ms STANDARD_DEVIATION 26.2 |
| Race/Ethnicity, Customized Black (or African American) | 2 Participants |
| Race/Ethnicity, Customized White | 9 Participants |
| Serum Calcium Concentration | 2.41 mmol/L STANDARD_DEVIATION 0.08 |
| Serum Corrected Calcium Concentration | 2.42 mmol/L STANDARD_DEVIATION 0.08 |
| Serum Intact Parathyroid Hormone Concentration | 66.10 pmol/L STANDARD_DEVIATION 57.57 |
| Serum Ionized Calcium Concentration | 1.16 mmol/L STANDARD_DEVIATION 0.07 |
| Serum Phosphorus Concentration | 1.79 mmol/L STANDARD_DEVIATION 0.45 |
| Serum Potassium Concentration | 4.77 mmol/L STANDARD_DEVIATION 0.55 |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 5 Participants |
| Temperature | 36.6 degrees celsius STANDARD_DEVIATION 0.3 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 6 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Change From Baseline in Blood Pressure at End of Study
Time frame: Baseline and day 30 (end of study)
Population: Treated participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etelcalcetide | Change From Baseline in Blood Pressure at End of Study | Systolic blood pressure | 0.2 mmHg | Standard Deviation 17.5 |
| Etelcalcetide | Change From Baseline in Blood Pressure at End of Study | Diastolic blood pressure | 3.8 mmHg | Standard Deviation 8.5 |
Primary
Change From Baseline in Corrected (Bazett) QT Interval at End of Study
Time frame: Baseline and day 30 (end of study)
Population: Treated participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etelcalcetide | Change From Baseline in Corrected (Bazett) QT Interval at End of Study | -2.1 ms | Standard Deviation 32.2 |
Primary
Change From Baseline in Corrected (Fridericia) QT Interval at End of Study
Time frame: Baseline and day 30 (end of study)
Population: Treated participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etelcalcetide | Change From Baseline in Corrected (Fridericia) QT Interval at End of Study | -0.5 ms | Standard Deviation 23.3 |
Primary
Change From Baseline in Heart Rate at End of Study
Time frame: Baseline and day 30 (end of study)
Population: Treated participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etelcalcetide | Change From Baseline in Heart Rate at End of Study | -4.5 beats/minute | Standard Deviation 9.3 |
Primary
Change From Baseline in Intact Parathyroid Hormone (iPTH) Levels Over Time
Time frame: Baseline and day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)
Population: Treated participants with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etelcalcetide | Change From Baseline in Intact Parathyroid Hormone (iPTH) Levels Over Time | Day 1, 4 hours | -29.44 pmol/L | Standard Deviation 37.16 |
| Etelcalcetide | Change From Baseline in Intact Parathyroid Hormone (iPTH) Levels Over Time | Day 3 | -14.81 pmol/L | Standard Deviation 37.81 |
| Etelcalcetide | Change From Baseline in Intact Parathyroid Hormone (iPTH) Levels Over Time | Day 8 | -10.20 pmol/L | Standard Deviation 38.16 |
| Etelcalcetide | Change From Baseline in Intact Parathyroid Hormone (iPTH) Levels Over Time | Day 10 | -4.68 pmol/L | Standard Deviation 37.92 |
| Etelcalcetide | Change From Baseline in Intact Parathyroid Hormone (iPTH) Levels Over Time | Day 30 | -19.81 pmol/L | Standard Deviation 51.29 |
Primary
Change From Baseline in PR Interval at End of Study
Time frame: Baseline and day 30 (end of study)
Population: Treated participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etelcalcetide | Change From Baseline in PR Interval at End of Study | -3.6 ms | Standard Deviation 13.9 |
Primary
Change From Baseline in QRS Interval at End of Study
Time frame: Baseline and day 30 (end of study)
Population: Treated participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etelcalcetide | Change From Baseline in QRS Interval at End of Study | -2.6 ms | Standard Deviation 6.8 |
Primary
Change From Baseline in QT Interval at End of Study
Time frame: Baseline and day 30 (end of study)
Population: Treated participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etelcalcetide | Change From Baseline in QT Interval at End of Study | 2.8 ms | Standard Deviation 21.6 |
Primary
Change From Baseline in Serum Corrected Calcium Concentration Over Time
When albumin was less than 4.0 mg/dL, the calcium concentration was corrected according to the formula: cCa (mmol/L) = measured total serum calcium (mmol/L) + 0.02 (40 - serum albumin \[g/L\]).
Time frame: Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)
Population: Treated participants with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etelcalcetide | Change From Baseline in Serum Corrected Calcium Concentration Over Time | Day 1, 4 hours | -0.03 mmol/L | Standard Deviation 0.12 |
| Etelcalcetide | Change From Baseline in Serum Corrected Calcium Concentration Over Time | Day 3 | -0.03 mmol/L | Standard Deviation 0.08 |
| Etelcalcetide | Change From Baseline in Serum Corrected Calcium Concentration Over Time | Day 8 | 0.03 mmol/L | Standard Deviation 0.09 |
| Etelcalcetide | Change From Baseline in Serum Corrected Calcium Concentration Over Time | Day 10 | 0.03 mmol/L | Standard Deviation 0.07 |
| Etelcalcetide | Change From Baseline in Serum Corrected Calcium Concentration Over Time | Day 30 | -0.01 mmol/L | Standard Deviation 0.16 |
Primary
Change From Baseline in Serum Phosphorus Concentration at End of Study
Time frame: Baseline and day 30 (end of study)
Population: Treated participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etelcalcetide | Change From Baseline in Serum Phosphorus Concentration at End of Study | 0.08 mmol/L | Standard Deviation 0.31 |
Primary
Change From Baseline in Serum Potassium Concentration at End of Study
Time frame: Baseline and day 30 (end of study)
Population: Treated participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etelcalcetide | Change From Baseline in Serum Potassium Concentration at End of Study | 0.45 mmol/L | Standard Deviation 1.21 |
Primary
Change From Baseline in Temperature at End of Study
Time frame: Baseline and day 30 (end of study)
Population: Treated participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etelcalcetide | Change From Baseline in Temperature at End of Study | 0.1 degrees celsius | Standard Deviation 0.4 |
Primary
Common Treatment-emergent Adverse Events
A treatment-emergent adverse event is any adverse event (AE) that begins or worsens after the initial dose of study drug (etelcalcetide) and up to 30 days after the last dose. Common adverse events were defined as adverse events occurring in at least 2 participants. The Medical Dictionary for Regulatory Activities (MedDRA) version 21.0 was used for coding all adverse events.
Time frame: 30 days
Population: Participants who received at least 1 dose of etelcalcetide (safety analysis set)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Etelcalcetide | Common Treatment-emergent Adverse Events | Headache | 2 Participants |
| Etelcalcetide | Common Treatment-emergent Adverse Events | Calcium ionised decreased | 2 Participants |
| Etelcalcetide | Common Treatment-emergent Adverse Events | Hypotension | 2 Participants |
Secondary
Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero Infinity (AUCinf)
Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL. Area under the concentration-time curve from time zero to infinite time (AUCinf) was estimated using the linear trapezoidal method.
Time frame: 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose
Population: Pharmacokinetic analysis set with available AUCinf data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etelcalcetide | Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero Infinity (AUCinf) | 1700 hr*ng/mL | Standard Deviation 1420 |
Secondary
Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast)
Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL. Area under the curve for plasma etelcalcetide from time zero to the last quantifiable concentration (AUClast) was estimated using the linear trapezoidal method.
Time frame: 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose
Population: Pharmacokinetic analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etelcalcetide | Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) | 1360 hr*ng/mL | Standard Deviation 1110 |
Secondary
Change From Baseline in Serum Ionized Calcium Concentration
Time frame: Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)
Population: Treated participants with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etelcalcetide | Change From Baseline in Serum Ionized Calcium Concentration | Day 1, 4 hours | -0.05 mmol/L | Standard Deviation 0.13 |
| Etelcalcetide | Change From Baseline in Serum Ionized Calcium Concentration | Day 3 | -0.01 mmol/L | Standard Deviation 0.08 |
| Etelcalcetide | Change From Baseline in Serum Ionized Calcium Concentration | Day 8 | 0.02 mmol/L | Standard Deviation 0.07 |
| Etelcalcetide | Change From Baseline in Serum Ionized Calcium Concentration | Day 10 | 0.01 mmol/L | Standard Deviation 0.06 |
| Etelcalcetide | Change From Baseline in Serum Ionized Calcium Concentration | Day 30 | 0.03 mmol/L | Standard Deviation 0.06 |
Secondary
Change From Baseline in Serum Total Calcium Concentration
Time frame: Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)
Population: Treated participants with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etelcalcetide | Change From Baseline in Serum Total Calcium Concentration | Day 1, 4 hours | -0.02 mmol/L | Standard Deviation 0.12 |
| Etelcalcetide | Change From Baseline in Serum Total Calcium Concentration | Day 3 | -0.02 mmol/L | Standard Deviation 0.08 |
| Etelcalcetide | Change From Baseline in Serum Total Calcium Concentration | Day 8 | 0.03 mmol/L | Standard Deviation 0.08 |
| Etelcalcetide | Change From Baseline in Serum Total Calcium Concentration | Day 10 | 0.02 mmol/L | Standard Deviation 0.08 |
| Etelcalcetide | Change From Baseline in Serum Total Calcium Concentration | Day 30 | -0.01 mmol/L | Standard Deviation 0.16 |
Secondary
Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide
Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL.
Time frame: 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose
Population: The pharmacokinetic analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etelcalcetide | Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide | 50.8 ng/mL | Standard Deviation 29.3 |
Secondary
Number of Participants Who Developed Anti-etelcalcetide Binding Antibodies
Samples were collected predose and at end of study (day 30) and tested for anti etelcalcetide binding antibodies using a validated immunoassay. Developing antibody binding was defined as participants who were binding antibody positive postbaseline with a negative result at baseline.
Time frame: Baseline and day 30
Population: Treated participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Etelcalcetide | Number of Participants Who Developed Anti-etelcalcetide Binding Antibodies | 2 Participants |
Secondary
Number of Participants With Treatment-emergent Adverse Events
A treatment-emergent adverse event is any adverse event that begins or worsens after the initial dose of study drug (etelcalcetide) and up to 30 days after the last dose. The severity of each adverse event was graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 1 = Mild (asymptomatic or mild symptoms), Grade 2 = Moderate (minimal, local or noninvasive intervention indicated), Grade 3 = Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated, Grade 4 = Life-threatening consequences; urgent intervention indicated, and Grade 5 = Death related to AE.
Time frame: 30 days
Population: All Treated participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Etelcalcetide | Number of Participants With Treatment-emergent Adverse Events | Any adverse event | 6 Participants |
| Etelcalcetide | Number of Participants With Treatment-emergent Adverse Events | Adverse events ≥ grade 3 | 2 Participants |
| Etelcalcetide | Number of Participants With Treatment-emergent Adverse Events | Adverse events ≥ grade 4 | 0 Participants |
| Etelcalcetide | Number of Participants With Treatment-emergent Adverse Events | Serious adverse events | 0 Participants |
| Etelcalcetide | Number of Participants With Treatment-emergent Adverse Events | AEs leading to discontinuation of etelcalcetide | 0 Participants |
| Etelcalcetide | Number of Participants With Treatment-emergent Adverse Events | Fatal adverse events | 0 Participants |
| Etelcalcetide | Number of Participants With Treatment-emergent Adverse Events | Treatment-related adverse events | 0 Participants |
| Etelcalcetide | Number of Participants With Treatment-emergent Adverse Events | Treatment-related AEs ≥ grade 3 | 0 Participants |
Secondary
Terminal Half-life (T1/2,z) of Etelcalcetide
Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL. Terminal half life of plasma etelcalcetide (t1/2,z) was calculated as t1/2,z = ln(2)/λz, where λz is the first-order terminal rate constant estimated by linear regression of the terminal log-linear phase.
Time frame: 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose
Population: Pharmacokinetic analysis set with available T1/2,z data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etelcalcetide | Terminal Half-life (T1/2,z) of Etelcalcetide | 5.77 days | Standard Deviation 2.66 |
Secondary
Time to Maximum Concentration (Tmax) of Etelcalcetide
Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL.
Time frame: 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose
Population: The pharmacokinetic concentration analysis set was composed of all participants who received etelcalcetide and had at least 1 pharmacokinetic sample collected.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Etelcalcetide | Time to Maximum Concentration (Tmax) of Etelcalcetide | 0.17 hours |