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Etelcalcetide for Children with Kidney Disease and Secondary Hyperparathyroidism

This study is testing a medication called Etelcalcetide in children and teenagers (ages 28 days to 18 years) who have chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) and are on hemodialysis. SHPT is a common problem in children with CKD that can cause bone issues and affect growth. Etelcalcetide has been approved for adults with SHPT and CKD on hemodialysis because it helps control parathyroid hormone (iPTH), calcium, and phosphorus levels. Researchers want to see if Etelcalcetide can reduce iPTH levels by at least 30% in pediatric patients compared to standard care, which includes vitamin D, calcium, and phosphate binders. To join, your child must be on hemodialysis, have SHPT with specific iPTH levels (at least 300 pg/mL), and have a certain calcium level (at least 9.0 mg/dL). The study is currently unclear on its recruitment status and plans to enroll 56 participants.

Study design
This is an interventional study with a planned enrollment of 56 participants. It compares Etelcalcetide to standard care for children with secondary hyperparathyroidism and chronic kidney disease.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main study goals are measured between Baseline and Weeks 20-27.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03633708

A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis

Recruiting
PHASE3Ages 0–18InterventionalTreatment
Amgen
~56 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:EtelcalcetideStandard of Care

At a glance

Recruiting sites
19 of 43 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants Achieving a ≥ 30% Reduction from Baseline in Mean iPTH During the Efficacy Assessment Period (EAP)
Measured over Baseline and Weeks 20-27
+1 more outcome measured

Conditions

Secondary Hyperparathyroidism
Chronic Kidney Disease

Explore related trials

Chronic Kidney DiseaseSecondary HyperparathyroidismCalciumParathyroid Hormone

NCT03633708

Where you'd take part

This study runs at 43 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Ankara Bilkent Sehir Hastanesi

    Ankara, Turkey (Türkiye)no site contact published

    Recruiting

  • Baskent Universitesi Ankara Hastanesi

    Ankara, Turkey (Türkiye)no site contact published

    Recruiting

  • Centro Infantil Del Rinon

    San Miguel de Tucumán, Tucumán Province, Argentinano site contact published

    Recruiting

  • Childrens Hospital of Los Angeles

    Los Angeles, Californiano site contact published

    Recruiting

  • Childrens Hospital of Philadelphia

    Philadelphia, Pennsylvaniano site contact published

    Recruiting

  • Childrens Mercy Hospital

    Kansas City, Missourino site contact published

    Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohiono site contact published

    Recruiting

  • Ege Universitesi Tip Fakultesi Hastanesi

    Izmir, Turkey (Türkiye)no site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • MD · STUDY_DIRECTOR · Amgen

Who to contact

Amgen Call Center
[email protected]
866-572-6436
Email the study team

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Eligibility criteria

Inclusion

Age of 28 days \< 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 ≥ 300 pg/mL (32 pmol/L) during screening, on separate days and within 2 weeks of enrolment.
Serum corrected calcium (cCa) value ≥ 9.0 mg/dL (2.25 mmol/L) for participants ≥ 2 years of age and older and serum cCa value ≥ 9.6 mg/dL (2.4 mmol/L) for participants 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 trial.
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.

Exclusion

History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrhythmia's or other conditions associated with prolonged QT interval.
Anticipated or scheduled parathyroidectomy during the trial period.
Anticipated or scheduled kidney transplant during the trial period.
Participant has received a parathyroidectomy within 6 months prior to randomization.
Use of concomitant medications that may prolong the corrected QT interval (eg, ondansetron, albuterol, sotalol, amiodarone, erythromycin, or clarithromycin). Refer to CredibleMeds.org for guidance. Certain medications may be allowed based on review by the medical monitor and require additional electrocardiogram (ECG) monitoring and potential electrolyte monitoring.
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.
All herbal medicines (eg, St. John's wort), vitamins, and supplements consumed by the participant within the 30 days prior to randomization, and continuing use if applicable, will be reviewed by the Principal Investigator and the Amgen Medical Monitor. Written documentation of the review and Amgen acknowledgment is required for participant participation.
Use of any over-the-counter or prescription medications within the 14 days or 5 half-lives (whichever is longer) prior to randomization that are not established therapies for participants with renal disease or other conditions secondary to renal disease will be reviewed by the Principal Investigator and the Amgen Medical Monitor. Written documentation of the review and Amgen acknowledgment is required for participant participation. Paracetamol for analgesia will be allowed.
Participant has significant abnormalities on the most recent central laboratory test during the screening period prior to enrollment per the Investigator including but not limited to the following: a. Serum transaminase (alanine aminotransferase \[ALT\] or serum glutamic pyruvic transaminase \[SGPT\], aspartate aminotransferase \[AST\] or serum glutamic oxaloacetic transaminase \[SGOT\]) \> 2.0 times the upper limit of normal (ULN).
Corrected QT interval (QTc) \> 500 ms, using Bazett's formula.
QTc ≥ 450 to ≤ 500 ms, using Bazett's formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist.
Participant has a clinically significant ECG abnormality during screening that, in the opinion of the investigator, could pose a risk to participant safety or interfere with the trial evaluation.
Participants aged 28 days to 6 months of age who were born prematurely at \< 36 weeks gestational age.
Female participant is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 3 months after the last dose of etelcalcetide. (Females of childbearing potential should only be included in the trial after a confirmed menstrual period and a negative highly sensitive serum pregnancy test within 7 days prior to the first dose of investigational product).
Female participants of childbearing potential unwilling to use 1 highly-effective or acceptable method of contraception during treatment and for an additional 3 months after the last dose of investigational product.
Participant has known sensitivity to etelcalcetide or excipients to be administered during dosing.
Participant likely to not be available to complete all protocol-required trial visits or procedures, and/or to comply with all required trial procedures (eg, to the best of the participant and investigator's knowledge).
History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion.
Participant has previously entered this trial.

What this trial measures

  • Percentage of Participants Achieving a ≥ 30% Reduction from Baseline in Mean iPTH During the Efficacy Assessment Period (EAP)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 EAPBaseline and Weeks 20-27

    Percent Change from Baseline in Mean iPTH During EAP (defined as weeks 20 through 27).