Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Neoplasms

Symptoms and General Pathology

Gland and Hormone Related Diseases

Rare Diseases

Kidney Diseases

Neoplasm Metastasis

Hyperparathyroidism

Hyperparathyroidism, Secondary

Renal Insufficiency, Chronic

Renal Insufficiency

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Chronic Disease

Disease Attributes

Neoplastic Processes

Parathyroid Diseases

Endocrine System Diseases

Chronic Graft Versus Host Disease

Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.

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.

Etelcalcetide

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.

A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Haemodialysis

An Open-label, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Etelcalcetide (AMG 416) in Paediatric Subjects Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Maintenance Haemodialysis

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

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.

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 \[g/L\]).

Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL.

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.

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.

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.

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.

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.

Amgen

Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Participants received a single, intravenous bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.

Age, Continuous

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race/Ethnicity, Customized

Serum Corrected Calcium Concentration

Serum Phosphorus Concentration

Serum Potassium Concentration

Serum Intact Parathyroid Hormone Concentration

Serum Calcium Concentration

Serum Ionized Calcium Concentration

Heart Rate

Temperature

Systolic blood pressure

Diastolic blood pressure

Blood Pressure

The PR interval is measured using electrocardiography (ECG) and is the period from the beginning of the P wave (the onset of atrial depolarization) until the beginning of the QRS complex (the onset of ventricular depolarization); it is normally between 120 and 200 milliseconds (ms) in duration.

PR Interval

The QRS interval measured during ECG, denotes depolarization of the ventricles, between the beginning of the Q wave and the end of the S wave.

QRS Interval

The QT interval measured during ECG is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. The QT interval represents electrical depolarization and repolarization of the ventricles.

QT Interval

Corrected (Bazett) QT Interval (QTcB)

Corrected (Fridericia) QT Interval (QTcF)

Study Director

Headache

Calcium ionised decreased

Hypotension

Participants who received at least 1 dose of etelcalcetide (safety analysis set)

Common Treatment-emergent Adverse Events

Day 1, 4 hours

Day 3

Day 8

Day 10

Day 30

Treated participants with available data at each time point.

Change From Baseline in Serum Corrected Calcium Concentration Over Time

Change From Baseline in Serum Phosphorus Concentration at End of Study

Change From Baseline in Serum Potassium Concentration at End of Study

Change From Baseline in Intact Parathyroid Hormone (iPTH) Levels Over Time

Change From Baseline in Heart Rate at End of Study

Change From Baseline in Temperature at End of Study

Change From Baseline in Blood Pressure at End of Study

Change From Baseline in PR Interval at End of Study

Change From Baseline in QRS Interval at End of Study

Change From Baseline in QT Interval at End of Study

Change From Baseline in Corrected (Bazett) QT Interval at End of Study

Change From Baseline in Corrected (Fridericia) QT Interval at End of Study

Change From Baseline in Serum Total Calcium Concentration

Change From Baseline in Serum Ionized Calcium Concentration

Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide

The pharmacokinetic concentration analysis set was composed of all participants who received etelcalcetide and had at least 1 pharmacokinetic sample collected.

Time to Maximum Concentration (Tmax) of Etelcalcetide

Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast)

Pharmacokinetic analysis set with available AUCinf data

Spots Global Cancer Trial Database for A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Haemodialysis

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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