NCT03633708 · Amgen
A Study of Etelcalcetide in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
What this study is about
This is a Phase 3 Study of Etelcalcetide in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
View original scientific description
This is a Phase 3 Study of Etelcalcetide in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Interventions
DRUG
Etelcalcetide
Etelcalcetide has been shown to be safe and efficacious in treating adult CKD patients with SHPT by simultaneously controlling 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
OTHER
Standard of Care
Standard of care, which can include therapy with vitamin D sterols, Ca supplementation, and/or phosphate binders
Primary outcome measures
Percentage of Participants Achieving a ≥ 30% Reduction from Baseline in Mean iPTH During the Efficacy Assessment Period (EAP)
Time frame: Baseline and Weeks 20-27
Achievement of at least a 30% reduction from baseline in mean iPTH during the EAP (defined as weeks 20 through 27).
Percentage Change from Baseline in Mean iPTH During the EAP
Time frame: Baseline and Weeks 20-27
Percent Change from Baseline in Mean iPTH During EAP (defined as weeks 20 through 27).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age of 28 days or older and less than 18 years
- 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 for at least 4 weeks prior to screening and throughout the duration of the study.
- No more than a maximum prescribed dose change of 50% for active vitamin D sterols/phosphate binders/Ca supplements within the 2 weeks prior to screening assessments and remain stable.
- SHPT not due to vitamin D deficiency, per investigator assessment.
Where
- Los Angeles, California
- Aurora, Colorado
- Kansas City, Missouri
- New York, New York
- Cincinnati, Ohio
- Cleveland, Ohio
- Oklahoma City, Oklahoma
- Philadelphia, Pennsylvania
- Dallas, Texas
- Salt Lake City, Utah
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2026 · Source of record for eligibility and locations