Study of Etelcalceide in Pediatric Subjects With Secondary Hyperparathyroidism and CKD on Hemodialysis
Age: Birth - 18 years
Healthy Subjects: No
Study Phase: Phase 3
Recruitment Status: Recruiting
Start Date: April 29, 2019
End Date: January 31, 2023
- Dry weight ≥ 7 kg during screening.
- Diagnosed with CKD and SHPT undergoing hemodialysis at the time of screening.
- 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.
- 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.
- Dialysate Ca level ≥ 2.5 mEq/L during screening.
- SHPT not due to vitamin D deficiency, per investigator assessment. Exclusion
- Anticipated or scheduled parathyroidectomy or kidney transplant during the study period.
- Subject has received a parathyroidectomy within 6 months prior to randomization.
- Receipt of cinacalcet therapy within 30 days prior to screening assessments and through randomization.
- Receipt of etelcalcetide within 6 months prior to screening assessments and through randomization.