Study of Etelcalceide in Pediatric Subjects With Secondary Hyperparathyroidism and CKD on Hemodialysis

• Status: Recruiting
• Trial end date: 2023-01-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen

Criteria

Inclusion criteria

• 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.