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New hope for kids on dialysis: drug targets hormone imbalance

NCT ID NCT03633708

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests etelcalcetide (Parsabiv) in 56 children aged 28 days to under 18 years who have secondary hyperparathyroidism and chronic kidney disease and are on hemodialysis. The drug aims to lower parathyroid hormone levels and improve mineral balance. Participants receive either etelcalcetide or standard care (vitamin D, calcium, phosphate binders) to compare effectiveness and safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
etelcalcetide (Parsabiv)
What this could lead to
If it works, this could provide a new treatment option to better control hormone levels and mineral balance in children with kidney disease on dialysis.
What could go wrong
This is a relatively small trial (56 kids) and the drug is already approved for adults, but children may respond differently or have unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 56 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2019

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria * 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 Criteria Disease Related * 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. 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.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome secondary hyperparathyroidism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic kidney disease Secondary hyperparathyroidism

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    19 sites in 5 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • All India Institute of Medical Sciences

    ACTIVE_NOT_RECRUITING

    New Delhi, National Capital Territory of Delhi, 110029, India

  • Ankara Bilkent Sehir Hastanesi

    RECRUITING

    Ankara, 06800, Turkey (Türkiye)

  • Asan Medical Center

    TERMINATED

    Seoul, 05505, South Korea

  • Baskent Universitesi Ankara Hastanesi

    RECRUITING

    Ankara, 06490, Turkey (Türkiye)

  • Centro Infantil Del Rinon

    RECRUITING

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • Childrens Hospital Colorado

    TERMINATED

    Aurora, Colorado, 80045, United States

  • Childrens Hospital of Los Angeles

    RECRUITING

    Los Angeles, California, 90027, United States

  • Childrens Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Childrens Medical Center Dallas

    TERMINATED

    Dallas, Texas, 75390, United States

  • Childrens Mercy Hospital

    RECRUITING

    Kansas City, Missouri, 64108, United States

  • Cincinnati Childrens Hospital Medical Center

    COMPLETED

    Cincinnati, Ohio, 45229, United States

  • Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Ege Universitesi Tip Fakultesi Hastanesi

    RECRUITING

    Izmir, 35040, Turkey (Türkiye)

  • Erciyes Universitesi Tip Fakultesi Hastanesi

    RECRUITING

    Kayseri, 38039, Turkey (Türkiye)

  • Firat Universitesi Tip Fakultesi Hastanesi

    RECRUITING

    Elâzığ, 23200, Turkey (Türkiye)

  • Fortis Flt Lt Rajan Dhall Hospital

    ACTIVE_NOT_RECRUITING

    New Delhi, National Capital Territory of Delhi, 110 070, India

  • Fresenius Escobar

    TERMINATED

    Belen de Escobar, Buenos Aires, B1625DUG, Argentina

  • Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi

    RECRUITING

    Ankara, 06500, Turkey (Türkiye)

  • Hacettepe Universitesi Tip Fakultesi Hastanesi

    RECRUITING

    Ankara, 06230, Turkey (Türkiye)

  • Hospital Italiano

    RECRUITING

    Cuidad Autonoma de Buenos Aires, Buenos Aires, C1199ABB, Argentina

  • Hospital Raja Perempuan Zainab II

    TERMINATED

    Kota Bharu, Kelantan, 15586, Malaysia

  • Hospital TuanKu Jaafar

    TERMINATED

    Seremban, Negeri Sembilan, 70300, Malaysia

  • Hospital Wanita Dan Kanak-Kanak Kuala Lumpur

    TERMINATED

    Kuala Lumpur, Kuala Lumpur, 50300, Malaysia

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi

    RECRUITING

    Istanbul, 34098, Turkey (Türkiye)

  • KLES Dr Prabhakar Kore Hospital and Medical Research Centre

    ACTIVE_NOT_RECRUITING

    Belagavi, Karnataka, 590010, India

  • Kaohsiung Veterans General Hospital

    TERMINATED

    Kaohsiung City, 81362, Taiwan

  • Linkou Chang Gung Memorial Hospital

    RECRUITING

    Taoyuan, 33305, Taiwan

  • Manipal Hospital

    ACTIVE_NOT_RECRUITING

    Bangalore, Karnataka, 560 017, India

  • Marmara Universitesi Tip Fakultesi Hastanesi

    RECRUITING

    Istanbul, 34890, Turkey (Türkiye)

  • Mount Sinai Kidney Center - B1 Renal Treatment

    COMPLETED

    New York, New York, 10029, United States

  • NRS Medical College and Hospital

    ACTIVE_NOT_RECRUITING

    Kolkata, West Bengal, 700014, India

  • National Cheng Kung University Hospital

    TERMINATED

    Tainan, 70403, Taiwan

  • National Childrens Specializated Hospital Okhmadit

    TERMINATED

    Kyiv, 01135, Ukraine

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 10041, Taiwan

  • National University Hospital

    RECRUITING

    Singapore, 119074, Singapore

  • Primary Childrens Hospital Outpatient Services

    RECRUITING

    Salt Lake City, Utah, 84113, United States

  • Pusan National University Yangsan Hospital

    TERMINATED

    Yangsan-si, Gyeongsangnam-do, 50612, South Korea

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

    COMPLETED

    Saint Petersburg, 198205, Russia

  • SBHI Pediatrics city clinical hospital of Saint Vladimir

    TERMINATED

    Moscow, 107014, Russia

  • Seoul National University Hospital

    TERMINATED

    Seoul, 110-744, South Korea

  • Sir Ganga Ram Hospital

    ACTIVE_NOT_RECRUITING

    New Delhi, National Capital Territory of Delhi, 110060, India

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

    TERMINATED

    Samara, 443095, Russia

  • The Childrens Hospital at Oklahoma University Medical Center

    COMPLETED

    Oklahoma City, Oklahoma, 73104, United States

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