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Randomized in a 3:1 ratio to receive etelcalcetide in addition to standard of care

Randomized in a 3:1 ratio to receive etelcalcetide in addition standard of care alone (control arm)

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

Etelcalcetide

Amgen Call Center

This is a Phase 3 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 subjects (age 28 days to 18 years) 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.

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

Phase 3, Randomized, Open-label, Controlled, Multiple Dose, Efficacy, Safety, Pharmacokinetic, and Pharmacodynamic Study of Etelcalcetide in Pediatric Subjects 28 Days to < 18 Years of Age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Achievement of at least a 30% reduction from baseline in mean iPTH during the EAP (defined as weeks 20 through 27).

Cmax will be collected and reported for the etelcalcetide arm only.

Cmin will be collected and reported for the etelcalcetide arm only.

To characterize the safety of etelcalcetide treatment based on adverse events. Nature, frequency, severity, and relationship to treatment of all adverse events, including those of special interest reported during the study.

Occurrence of hypocalcemia at any point in time, assessed by serum chemistry.

Occurrence of corrected serum Ca levels \<8.0 mg/dL (2.0 mmol/L) for subjects 2 to \< 18 years of age and \<8.6 mg/dL (2.15 mmol/L) for subjects 28 days to \<2 years of age during the study.

Occurrence of serum phosphorous levels below the lower limit of normal for age.

Occurrence of predialysis iPTH levels below the lower limit of normal for age.

To characterize the safety of etelcalcetide treatment based on vital signs.

Changes in tanner stage at scheduled visits.

To characterize change in laboratory markers of CKD following etelcalcetide treatment.

Mean change from baseline in predialysis iPTH during the EAP (defined as weeks 20 through 27).

Percentage change from baseline in predialysis iPTH during the EAP (defined as weeks 20 through 27).

Percentage change from baseline in corrected total serum calcium during the EAP (defined as weeks 20 through 27).

Percentage change from baseline in corrected total serum phosphorous during the EAP (defined as weeks 20 through 27).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Etelcalcetide in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis	NCT03633708	Secondary Hyper... Chronic Kidney ...	Etelcalcetide	0 Years - 18 Years	Amgen
A Study of Etelcalcetide in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis	NCT03633708	Secondary Hyper... Chronic Kidney ...	Etelcalcetide	0 Years - 18 Years	Amgen

Spots Global Cancer Trial Database for shpt

Every month we try and update this database with for shpt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for shpt

Every month we try and update this database with for shpt cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for shpt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.