Home
Clinical Trials
NCT03633708

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

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-29

Study Completion Date

2029-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a Phase 3 Study of Etelcalcetide in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Secondary Hyperparathyroidism Chronic Kidney Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

sHPT CKD pediatric Secondary Hyperparathyroidism Chronic Kidney disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Etelcalcetide

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

Group Type EXPERIMENTAL

Etelcalcetide

Intervention Type DRUG

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

Control

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

Group Type ACTIVE_COMPARATOR

Etelcalcetide

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Etelcalcetide

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Parsabiv

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Exclusion Criteria

* 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 study period.
* Anticipated or scheduled kidney transplant during the study period.
* Subject has received a parathyroidectomy within 6 months prior to randomization.

Other Medical Conditions

* History of other malignancy, except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years. Prior/Concomitant Therapy
* 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.
* 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 subject 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 subject 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 subjects 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 subject participation. Paracetamol for analgesia will be allowed.

Prior/Concurrent Clinical Study Experience • Currently receiving treatment in another investigational device or drug study, or less than 30 days or 5 half-lives (whichever is longer) since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.

Diagnostic Assessments During Screening

* Subject 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.
* Subject has a clinically significant electrocardiogram (ECG) abnormality during screening that, in the opinion of the investigator, could pose a risk to subject safety or interfere with the study evaluation.

Within the 60 days prior to enrollment

• New onset or worsening of a pre-existing seizure disorder.

Other Exclusions

* Subjects aged 28 days to 6 months of age who were born prematurely at \< 36 weeks gestational age.
* Female subject 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 study 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 subjects 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.
* Subject has known sensitivity to etelcalcetide or excipients to be administered during dosing.
* Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, to the best of the subject 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 subject safety or interfere with the study evaluation, procedures, or completion.
* Subject has previously entered this study

Minimum Eligible Age

0 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

MD

Role: STUDY_DIRECTOR

Amgen

Review the countries where the study has at least one active or historical site.

United States Argentina India Malaysia Russia Singapore South Korea Taiwan Turkey (Türkiye) Ukraine

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Amgen Call Center

Role: CONTACT

Phone: 866-572-6436

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017-002411-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

20140315

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Etelcalcetide

Etelcalcetide

Control

Etelcalcetide

Interventions

Etelcalcetide

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Amgen

Responsible Party

Principal Investigators

MD

Locations

Childrens Hospital of Los Angeles

Childrens Hospital Colorado

Childrens Mercy Hospital

Mount Sinai Kidney Center - B1 Renal Treatment

Cincinnati Childrens Hospital Medical Center

Cleveland Clinic Foundation

The Childrens Hospital at Oklahoma University Medical Center

Childrens Hospital of Philadelphia

Childrens Medical Center Dallas

Primary Childrens Hospital Outpatient Services

Fresenius Escobar

Hospital Italiano

Centro Infantil Del Rinon

Manipal Hospital

KLES Dr Prabhakar Kore Hospital and Medical Research Centre

Fortis Flt Lt Rajan Dhall Hospital

All India Institute of Medical Sciences

Sir Ganga Ram Hospital

NRS Medical College and Hospital

Hospital Raja Perempuan Zainab II

Hospital Wanita Dan Kanak-Kanak Kuala Lumpur

Hospital TuanKu Jaafar

SBHI Pediatrics city clinical hospital of Saint Vladimir

SBHI Children's City Multidisciplinary Clinical Specialized Center of High Medical Technologies

State Budgetary Healthcare Institution Samara Regional Clinical Hospital na V D Seredavin

National University Hospital

Asan Medical Center

Seoul National University Hospital

Pusan National University Yangsan Hospital

Kaohsiung Veterans General Hospital

National Cheng Kung University Hospital

National Taiwan University Hospital

Linkou Chang Gung Memorial Hospital

Hacettepe Universitesi Tip Fakultesi Hastanesi

Baskent Universitesi Ankara Hastanesi

Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi

Ankara Bilkent Sehir Hastanesi

Firat Universitesi Hastanesi

Istanbul Universitesi Cerrahpasa Tip Fakultesi

Marmara Universitesi Tip Fakultesi Hastanesi

Ege Universitesi Tip Fakultesi Hastanesi

Erciyes Universitesi Tip Fakultesi Hastanesi

National Childrens Specializated Hospital Okhmadit

Countries

Central Contacts

Amgen Call Center

Related Links

Other Identifiers

2017-002411-34

20140315