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Completed

NCT Number: NCT02833857

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

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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Key information

Conditions

Chronic Kidney Disease, Secondary Hyperparathyroidism Chronic Disease Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperparathyroidism Hyperparathyroidism, Secondary Kidney Diseases Male Urogenital Diseases Parathyroid Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Etelcalcetide

Drug

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.

Other names: AMG 416, Parsabiv

Primary outcomes

  1. Common Treatment-emergent Adverse Events

    Time frame: 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.

  2. Change From Baseline in Serum Corrected Calcium Concentration Over Time

    Time frame: 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]).

  3. Change From Baseline in Serum Phosphorus Concentration at End of Study

    Time frame: Baseline and day 30 (end of study)

  4. Change From Baseline in Serum Potassium Concentration at End of Study

    Time frame: Baseline and day 30 (end of study)

  5. 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)

  6. Change From Baseline in Heart Rate at End of Study

    Time frame: Baseline and day 30 (end of study)

  7. Change From Baseline in Temperature at End of Study

    Time frame: Baseline and day 30 (end of study)

  8. Change From Baseline in Blood Pressure at End of Study

    Time frame: Baseline and day 30 (end of study)

  9. Change From Baseline in PR Interval at End of Study

    Time frame: Baseline and day 30 (end of study)

  10. Change From Baseline in QRS Interval at End of Study

    Time frame: Baseline and day 30 (end of study)

  11. Change From Baseline in QT Interval at End of Study

    Time frame: Baseline and day 30 (end of study)

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

    Time frame: Baseline and day 30 (end of study)

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

    Time frame: Baseline and day 30 (end of study)

Secondary outcomes

  1. 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)

  2. 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)

  3. Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide

    Time frame: 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.

  4. Time to Maximum Concentration (Tmax) of Etelcalcetide

    Time frame: 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.

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

    Time frame: 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.

  6. Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero Infinity (AUCinf)

    Time frame: 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.

  7. Terminal Half-life (T1/2,z) of Etelcalcetide

    Time frame: 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.

  8. Number of Participants Who Developed Anti-etelcalcetide Binding Antibodies

    Time frame: 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.

  9. Number of Participants With Treatment-emergent Adverse Events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 14, 2016
Registry last updated
Jul 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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