Study of Etelcalceide in Pediatric Subjects With Secondary Hyperparathyroidism and CKD on Hemodialysis
Study of Etelcalceide in Pediatric Subjects With Secondary Hyperparathyroidism and CKD on Hemodialysis
Study of Etelcalcetide in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic
 Kidney Disease on Hemodialysis
SHPT is a common and serious co-morbidity that develops relatively early in the course of
 CKD, worsens with declining kidney function, and is associated with serious complications in
 children on dialysis. Children on dialysis experience a wide spectrum of bone abnormalities
 and growth retardation, in addition to increased risk for cardiovascular morbidity and
 mortality that manifests early in their adulthood. Traditional therapies for SHPT (eg,
 vitamin D sterols) are widely used in the pediatric dialysis population, and have the
 potential to aggravate complications of the disease by increasing serum calcium (Ca), serum
 phosphorus, and serum Ca times serum phosphorus product.

 Etelcalcetide has been shown to be safe and efficacious in treating adult CKD patients with
 SHPT by simultaneously controlling intact parathyroid hormone (iPTH), Ca, and phosphorus and
 has recently been approved for use in adult patients with SHPT treated with hemodialysis in
 both the United States and Europe. Although no previous studies have been conducted in
 pediatric patients with etelcalcetide (one single dose pharmacokinetic [PK] study is
 currently ongoing), Amgen anticipates minimal to moderate risk with a possibility of direct
 benefit to the pediatric subject in this study. The burden of complications of SHPT in the
 pediatric dialysis population and the limitations of current standard therapy, underscore the
 need for studies of etelcalcetide in these patients to address this unmet medical need and
 inform the pediatric nephrology community of the potential use of etelcalcetide in children
 on hemodialysis with critical safety and efficacy data.
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.