About the study

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

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.

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.