For Healthcare Professionals

A Study of Etelcalcetide in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis

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About the study

This is a Phase 3 Study of Etelcalcetide in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Dry weight ≥ 7 kg during screening.
  2. Diagnosed with CKD and SHPT undergoing hemodialysis at the time of screening.
  3. Diagnosis of SHPT with the mean of the 2 consecutive central laboratory iPTH values ≥ 400 pg/mL (42 pmol/L) during screening, on separate days and within 2 weeks of enrolment.
  4. Serum cCa value ≥ 9.0 mg/dL (2.25 mmol/L) for subjects ≥ 2 years of age and older and serum cCa value ≥ 9.6 mg/dL (2.4 mmol/L) for subjects 28 days to < 2 years of age obtained from the central laboratory during screening.
  5. Dialysate Ca level ≥ 2.5 mEq/L during screening.
  6. SHPT not due to vitamin D deficiency, per investigator assessment. Exclusion
  7. Anticipated or scheduled parathyroidectomy or kidney transplant during the study period.
  8. Subject has received a parathyroidectomy within 6 months prior to randomization.
  9. Receipt of cinacalcet therapy within 30 days prior to screening assessments and through randomization.
  10. Receipt of etelcalcetide within 6 months prior to screening assessments and through randomization.

EXCLUSION CRITERIA

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    Study Locations

    Enter your ZIP code/Postal code/PIN code to locate study sites near you:

    How to Apply


    Contact the study center to learn if this study is a good match for you.
    Phone iconCall 866-572-6436Email iconEmail Study Center

    Study’s details


    Contition

    Chronic Kidney Disease,Secondary Hyperparathyroidism

    Age

    0+

    Phase

    Phase 3

    Participants needed

    56

    Est. Completion Date

    Jan 2026

    Treatment type

    Interventional


    Sponsor

    Amgen

    ClinicalTrials.gov identifier

    NCT03633708

    Study number

    20140315

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