A Phase 1 interventional study of Etelcalcetide in Chronic Kidney Disease, Secondary Hyperparathyroidism, sponsored by Amgen. Completed at 13 sites in 6 countries. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2019-07-10.
Sponsored by Amgen · Phase 1, Interventional, and Treatment
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.
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Exclusion Criteria:
Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Drug: Etelcalcetide
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.
Also known as: AMG 416, Parsabiv
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
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)
Change From Baseline in Serum Phosphorus Concentration at End of Study
Time frame: Baseline and day 30 (end of study)
Change From Baseline in Serum Potassium Concentration at End of Study
Time frame: Baseline and day 30 (end of study)
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)
Change From Baseline in Heart Rate at End of Study
Time frame: Baseline and day 30 (end of study)
Change From Baseline in Temperature at End of Study
Time frame: Baseline and day 30 (end of study)
Change From Baseline in Blood Pressure at End of Study
Time frame: Baseline and day 30 (end of study)
Change From Baseline in PR Interval at End of Study
Time frame: Baseline and day 30 (end of study)
Change From Baseline in QRS Interval at End of Study
Time frame: Baseline and day 30 (end of study)
Change From Baseline in QT Interval at End of Study
Time frame: Baseline and day 30 (end of study)
Change From Baseline in Corrected (Bazett) QT Interval at End of Study
Time frame: Baseline and day 30 (end of study)
Change From Baseline in Corrected (Fridericia) QT Interval at End of Study
Time frame: Baseline and day 30 (end of study)
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)
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)
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
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
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
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
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
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
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
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.
| Milestone | Etelcalcetide |
|---|---|
| Started | 11 |
| Completed | 11 |
| Not completed | 0 |
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.
| Participants | Etelcalcetide |
|---|---|
| Headache | 2 |
| Calcium ionised decreased | 2 |
| Hypotension | 2 |
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 \[g/L\]).
| mmol/L | Etelcalcetide |
|---|---|
| Day 1, 4 hours | -0.03 ± 0.12 |
| Day 3 | -0.03 ± 0.08 |
| Day 8 | 0.03 ± 0.09 |
| Day 10 | 0.03 ± 0.07 |
| Day 30 | -0.01 ± 0.16 |
| mmol/L | Etelcalcetide |
|---|---|
| Change From Baseline in Serum Phosphorus Concentration at End of Study | 0.08 ± 0.31 |
| mmol/L | Etelcalcetide |
|---|---|
| Change From Baseline in Serum Potassium Concentration at End of Study | 0.45 ± 1.21 |
| pmol/L | Etelcalcetide |
|---|---|
| Day 1, 4 hours | -29.44 ± 37.16 |
| Day 3 | -14.81 ± 37.81 |
| Day 8 | -10.20 ± 38.16 |
| Day 10 | -4.68 ± 37.92 |
| Day 30 | -19.81 ± 51.29 |
| beats/minute | Etelcalcetide |
|---|---|
| Change From Baseline in Heart Rate at End of Study | -4.5 ± 9.3 |
| degrees celsius | Etelcalcetide |
|---|---|
| Change From Baseline in Temperature at End of Study | 0.1 ± 0.4 |
| mmHg | Etelcalcetide |
|---|---|
| Systolic blood pressure | 0.2 ± 17.5 |
| Diastolic blood pressure | 3.8 ± 8.5 |
| ms | Etelcalcetide |
|---|---|
| Change From Baseline in PR Interval at End of Study | -3.6 ± 13.9 |
| ms | Etelcalcetide |
|---|---|
| Change From Baseline in QRS Interval at End of Study | -2.6 ± 6.8 |
| ms | Etelcalcetide |
|---|---|
| Change From Baseline in QT Interval at End of Study | 2.8 ± 21.6 |
| ms | Etelcalcetide |
|---|---|
| Change From Baseline in Corrected (Bazett) QT Interval at End of Study | -2.1 ± 32.2 |
| ms | Etelcalcetide |
|---|---|
| Change From Baseline in Corrected (Fridericia) QT Interval at End of Study | -0.5 ± 23.3 |
| mmol/L | Etelcalcetide |
|---|---|
| Day 1, 4 hours | -0.02 ± 0.12 |
| Day 3 | -0.02 ± 0.08 |
| Day 8 | 0.03 ± 0.08 |
| Day 10 | 0.02 ± 0.08 |
| Day 30 | -0.01 ± 0.16 |
| mmol/L | Etelcalcetide |
|---|---|
| Day 1, 4 hours | -0.05 ± 0.13 |
| Day 3 | -0.01 ± 0.08 |
| Day 8 | 0.02 ± 0.07 |
| Day 10 | 0.01 ± 0.06 |
| Day 30 | 0.03 ± 0.06 |
Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL.
| ng/mL | Etelcalcetide |
|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide | 50.8 ± 29.3 |
Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL.
| hours | Etelcalcetide |
|---|---|
| Time to Maximum Concentration (Tmax) of Etelcalcetide | 0.17 (0.17 to 0.33) |
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.
| hr*ng/mL | Etelcalcetide |
|---|---|
| Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) | 1360 ± 1110 |
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.
| hr*ng/mL | Etelcalcetide |
|---|---|
| Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero Infinity (AUCinf) | 1700 ± 1420 |
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.
| days | Etelcalcetide |
|---|---|
| Terminal Half-life (T1/2,z) of Etelcalcetide | 5.77 ± 2.66 |
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.
| Participants | Etelcalcetide |
|---|---|
| Number of Participants Who Developed Anti-etelcalcetide Binding Antibodies | 2 |
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.
| Participants | Etelcalcetide |
|---|---|
| Any adverse event | 6 |
| Adverse events ≥ grade 3 | 2 |
| Adverse events ≥ grade 4 | 0 |
| Serious adverse events | 0 |
| AEs leading to discontinuation of etelcalcetide | 0 |
| Fatal adverse events | 0 |
| Treatment-related adverse events | 0 |
| Treatment-related AEs ≥ grade 3 | 0 |
Collected over 30 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Etelcalcetide | 0/11 (0%) | 0/11 (0%) | 6/11 (54.5%) |
| Event | Etelcalcetide |
|---|---|
| Calcium ionised decreasedInvestigations | 2/11 |
| HeadacheNervous system disorders | 2/11 |
| HypotensionVascular disorders | 2/11 |
| NauseaGastrointestinal disorders | 1/11 |
| VomitingGastrointestinal disorders | 1/11 |
| DizzinessNervous system disorders | 1/11 |
| ParaesthesiaNervous system disorders | 1/11 |
| Catheter placementSurgical and medical procedures | 1/11 |
| GastrostomySurgical and medical procedures | 1/11 |
| Age, Continuous(years) | Etelcalcetide |
|---|---|
| Mean | 10.3 ± 4.3 |
| Age, Customized(Participants) | Etelcalcetide |
|---|---|
| Children (2 to 11 years) | 5 |
| Adolescents (12 to 17 years) | 6 |
| Sex: Female, Male(Participants) | Etelcalcetide |
|---|---|
| Female | 6 |
| Male | 5 |
| Ethnicity (NIH/OMB)(Participants) | Etelcalcetide |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 9 |
| Unknown or Not Reported | 0 |
| Race/Ethnicity, Customized(Participants) | Etelcalcetide |
|---|---|
| Black (or African American) | 2 |
| White | 9 |
| Serum Corrected Calcium Concentration(mmol/L) | Etelcalcetide |
|---|---|
| Mean | 2.42 ± 0.08 |
| Serum Phosphorus Concentration(mmol/L) | Etelcalcetide |
|---|---|
| Mean | 1.79 ± 0.45 |
| Serum Potassium Concentration(mmol/L) | Etelcalcetide |
|---|---|
| Mean | 4.77 ± 0.55 |
11 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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