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

  • STATUS
    Recruiting
  • End date
    Jan 31, 2023
  • participants needed
    56
  • sponsor
    Amgen
Updated on 13 June 2021
vitamin d
kidney transplant
nephropathy
chronic kidney disease
vitamin
renal disease
parathyroid hormone
hyperparathyroidism
ergocalciferol
cinacalcet
secondary hyperparathyroidism
kidney disease
parathyroidectomy
parathyroid hormones
etelcalcetide

Summary

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

Description

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.

Details
Condition chronic renal insufficiency, Hyperparathyroidism, Chronic renal failure, Secondary hyperparathyroidism, Hyperparathyroidism (Pediatric), chronic kidney disease, chronic kidney disease (ckd)
Treatment Etelcalcetide
Clinical Study IdentifierNCT03633708
SponsorAmgen
Last Modified on13 June 2021

Eligibility

Yes No Not Sure

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
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