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Secondary HyperparathyroidismPhase 3NCT03633708

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

A Phase 3 study testing Etelcalcetide in people with Secondary Hyperparathyroidism and Chronic Kidney Disease, run by Amgen at 43 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a phase 3 trial of etelcalcetide in pediatric participants with secondary hyperparathyroidism (SHPT) and chronic kidney disease (CKD) on hemodialysis. Read more about this study

Who is it for?
Ages 0 to 18 years
What is being tested?
Etelcalcetide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
43 sitesin 10 countries
Study dates
29 Apr 2019to 31 Jan 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
  • Other Medical Conditions
  • History of other malignancy, except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years.
Show all 28Show fewer
  • 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. 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.
  • Prior/Concurrent Clinical Trial Experience • Currently receiving treatment in another investigational device or drug trial, or less than 30 days or 5 half-lives (whichever is longer) since ending treatment on another investigational device or drug trial(s). Other investigational procedures while participating in this trial are excluded.
  • Diagnostic Assessments During Screening
  • 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.
  • Within the 60 days prior to enrollment
  • New onset or worsening of a pre-existing seizure disorder.
  • Other Exclusions
  • 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.

Trial locations and contacts

43 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Amgen Call Center contact

866-572-6436

medinfo@amgen.com

43 sites in 10 countries

United States10 sites, 5 recruiting

  • Childrens Hospital Colorado

    Aurora, Colorado, 80045

    Terminated

  • Cincinnati Childrens Hospital Medical Center

    Cincinnati, Ohio, 45229

    Completed

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

    Recruiting

  • Childrens Medical Center Dallas

    Dallas, Texas, 75390

    Terminated

  • Childrens Mercy Hospital

    Kansas City, Missouri, 64108

    Recruiting

  • Childrens Hospital of Los Angeles

    Los Angeles, California, 90027

    Recruiting

  • Mount Sinai Kidney Center - B1 Renal Treatment

    New York, New York, 10029

    Completed

  • The Childrens Hospital at Oklahoma University Medical Center

    Oklahoma City, Oklahoma, 73104

    Completed

  • Childrens Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • Primary Childrens Hospital Outpatient Services

    Salt Lake City, Utah, 84113

    Recruiting

Other trials in United States

Turkey (Türkiye)9 sites, 9 recruiting

  • Hacettepe Universitesi Tip Fakultesi Hastanesi

    Ankara, 06230

    Recruiting

  • Baskent Universitesi Ankara Hastanesi

    Ankara, 06490

    Recruiting

  • Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi

    Ankara, 06500

    Recruiting

  • Ankara Bilkent Sehir Hastanesi

    Ankara, 06800

    Recruiting

  • Firat Universitesi Tip Fakultesi Hastanesi

    Elâzığ, 23200

    Recruiting

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi

    Istanbul, 34098

    Recruiting

  • Marmara Universitesi Tip Fakultesi Hastanesi

    Istanbul, 34890

    Recruiting

  • Ege Universitesi Tip Fakultesi Hastanesi

    Izmir, 35040

    Recruiting

  • Erciyes Universitesi Tip Fakultesi Hastanesi

    Kayseri, 38039

    Recruiting

Other trials in Turkey (Türkiye)

India6 sites

  • Manipal Hospital

    Bangalore, Karnataka, 560 017

    Active, not recruiting

  • KLES Dr Prabhakar Kore Hospital and Medical Research Centre

    Belagavi, Karnataka, 590010

    Active, not recruiting

  • NRS Medical College and Hospital

    Kolkata, West Bengal, 700014

    Active, not recruiting

  • Fortis Flt Lt Rajan Dhall Hospital

    New Delhi, National Capital Territory of Delhi, 110 070

    Active, not recruiting

  • All India Institute of Medical Sciences

    New Delhi, National Capital Territory of Delhi, 110029

    Active, not recruiting

  • Sir Ganga Ram Hospital

    New Delhi, National Capital Territory of Delhi, 110060

    Active, not recruiting

Other trials in India

Taiwan4 sites, 2 recruiting

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362

    Terminated

  • National Cheng Kung University Hospital

    Tainan, 70403

    Terminated

  • National Taiwan University Hospital

    Taipei, 10041

    Recruiting

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 33305

    Recruiting

Other trials in Taiwan

Argentina3 sites, 2 recruiting

  • Fresenius Escobar

    Belen de Escobar, Buenos Aires, B1625DUG

    Terminated

  • Hospital Italiano

    Cuidad Autonoma de Buenos Aires, Buenos Aires, C1199ABB

    Recruiting

  • Centro Infantil Del Rinon

    San Miguel de Tucumán, Tucumán Province, 4000

    Recruiting

Other trials in Argentina

Malaysia3 sites

  • Hospital Raja Perempuan Zainab II

    Kota Bharu, Kelantan, 15586

    Terminated

  • Hospital Wanita Dan Kanak-Kanak Kuala Lumpur

    Kuala Lumpur, Kuala Lumpur, 50300

    Terminated

  • Hospital TuanKu Jaafar

    Seremban, Negeri Sembilan, 70300

    Terminated

Other trials in Malaysia

Russia3 sites

  • SBHI Pediatrics city clinical hospital of Saint Vladimir

    Moscow, 107014

    Terminated

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

    Saint Petersburg, 198205

    Completed

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

    Samara, 443095

    Terminated

Other trials in Russia

South Korea3 sites

  • Asan Medical Center

    Seoul, 05505

    Terminated

  • Seoul National University Hospital

    Seoul, 110-744

    Terminated

  • Pusan National University Yangsan Hospital

    Yangsan-si, Gyeongsangnam-do, 50612

    Terminated

Other trials in South Korea

Singapore1 site, 1 recruiting

  • National University Hospital

    Singapore, 119074

    Recruiting

Other trials in Singapore

Ukraine1 site

  • National Childrens Specializated Hospital Okhmadit

    Kyiv, 01135

    Terminated

Other trials in Ukraine

About this study

Official title: 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

This is a phase 3 trial of etelcalcetide in pediatric participants with secondary hyperparathyroidism (SHPT) and chronic kidney disease (CKD) on hemodialysis.

Read the detailed 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 trials have been conducted in pediatric patients with etelcalcetide (one single dose pharmacokinetic [PK] trial is currently ongoing), Amgen anticipates minimal to moderate risk with a possibility of direct benefit to the pediatric participants (age 28 days to 18 years) in this trial. The burden of complications of SHPT in the pediatric dialysis population and the limitations of current standard therapy, underscore the need for trials 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.

Being tested
Etelcalcetide, Standard of Care
Keywords
sHPT, CKD, pediatric, Secondary Hyperparathyroidism, Chronic Kidney disease
Medical subject headings
Hyperparathyroidism, Secondary, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EtelcalcetideDrug

    Also called Parsabiv

    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

  • Standard of CareOther

    Standard of care, which can include therapy with vitamin D sterols, Ca supplementation, and/or phosphate binders

Study groups in NCT03633708
Study groupRoleWhat they receive
EtelcalcetideExperimentalParticipants are randomized in a 5:1 ratio to receive etelcalcetide in addition to standard of care versus standard of care alone.
Receives: Drug: Etelcalcetide; Other: Standard of Care
Standard of CareActive comparatorParticipants are randomized in a 5:1 ratio to receive etelcalcetide in addition to standard of care versus standard of care alone.
Receives: Other: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving a ≥ 30% Reduction from Baseline in Mean iPTH During the Efficacy Assessment Period (EAP)

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

    Measured: Baseline and Weeks 20-27

  2. Percentage Change from Baseline in Mean iPTH During the EAP

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

    Measured: Baseline and Weeks 20-27

Secondary outcomes (17)

  1. Maximum Serum Concentration (Cmax) of Etelcalcetide

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

    Measured: 10-30 minutes post dose on Day 1 and 10-30 minutes post dose on Weeks 5, 9, 13, 17, and 21

  2. Minimum Serum Concentration (Cmin) of Etelcalcetide

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

    Measured: 10-30 minutes post dose on Day 1 and 10-30 minutes post dose on Weeks 5, 9, 13, 17, and 21

  3. Number of Participants who Experienced Adverse Events (AEs)

    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 trial.

    Measured: Day 1 to 30 days after last dose of etelcalcetide (up to approximately 30 weeks)

  4. Frequency of Hypocalcemia

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

    Measured: Up to approximately 30 Weeks

  5. Number of Participants with Corrected Serum Ca Levels at any Time During the Trial

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

    Measured: Up to approximately 30 Weeks

  6. Number of Participants with Serum Phosphorous Levels Below Normal by Age Group

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

    Measured: Up to approximately 30 Weeks

  7. Number of Participants with Predialysis iPTH Levels Below Normal by Age Group

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

    Measured: Up to approximately 30 Weeks

  8. Change from Baseline in Systolic Blood Pressure

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

    Measured: Week -2, Week -1, Day1, and Weeks 4, 8, 12, 16, 20, 24, and 27

  9. Change from Baseline in Diastolic Blood Pressure

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

    Measured: Week -2, Week -1, Day1, and Weeks 4, 8, 12, 16, 20, 24, and 27

  10. Change from Baseline in Heart Rate

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

    Measured: Week -2, Week -1, Day1, and Weeks 4, 8, 12, 16, 20, 24, and 27

  11. Change in Tanner Stage

    Changes in tanner stage at scheduled visits.

    Measured: Week -2 and Week 27

  12. Change in Height

    Changes in height at scheduled visits.

    Measured: Day 1 and Week 27

  13. Change in Weight

    Changes in weight at scheduled visits.

    Measured: Week -2, Day 1, and Week 27

  14. Number of Participants Achieving ≥ 30% Reduction in iPTH from Baseline on two Consecutive Visits

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

    Measured: Up to approximately 30 Weeks

  15. Mean Change from Baseline in Predialysis iPTH from Baseline during the EAP

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

    Measured: Baseline and Weeks 20-27

  16. Percentage Change from Baseline in Corrected Total Serum Ca from Baseline During the EAP

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

    Measured: Baseline and Weeks 20-27

  17. Percentage Change from Baseline in Corrected Total Serum Phosphorous from Baseline During the EAP

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

    Measured: Baseline and Weeks 20-27

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2018
  2. Study start29 Apr 2019
  3. Primary completion31 Jan 2029 (estimated)
  4. Study completion31 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03633708
Sponsor's protocol ID
20140315
Other IDs
2017-002411-34, 2017
Status last verified
Feb 2026
First submitted
14 Aug 2018
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Etelcalcetide in people with Secondary Hyperparathyroidism and Chronic Kidney Disease, run by Amgen at 43 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States, Turkey (Türkiye), India, Taiwan, Argentina and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Amgen Call Center (866-572-6436, medinfo@amgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03633708.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

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