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

Recruiting now · Phase 3

Conditions studied: Secondary Hyperparathyroidism, Chronic Kidney Disease

In brief

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

Key facts

Study ID

NCT03633708

Run by

Amgen

People needed

56

Starts

2019-04-29

Expected to finish

2029-01-31

Last updated by the study team

2026-02-27

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• Childrens Hospital of Los Angeles — Los Angeles, California, United States (enrolling)
• Childrens Mercy Hospital — Kansas City, Missouri, United States (enrolling)
• Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)
• Childrens Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• Primary Childrens Hospital Outpatient Services — Salt Lake City, Utah, United States (enrolling)
• Hospital Italiano — Cuidad Autonoma de Buenos Aires, Buenos Aires, Argentina (enrolling)
• Centro Infantil Del Rinon — San Miguel de Tucumán, Tucumán Province, Argentina (enrolling)
• National University Hospital — Singapore, Singapore (enrolling)
• National Taiwan University Hospital — Taipei, Taiwan (enrolling)
• Linkou Chang Gung Memorial Hospital — Taoyuan, Taiwan (enrolling)
• Hacettepe Universitesi Tip Fakultesi Hastanesi — Ankara, Turkey (Türkiye) (enrolling)
• Baskent Universitesi Ankara Hastanesi — Ankara, Turkey (Türkiye) (enrolling)
• Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi — Ankara, Turkey (Türkiye) (enrolling)
• Ankara Bilkent Sehir Hastanesi — Ankara, Turkey (Türkiye) (enrolling)
• Firat Universitesi Tip Fakultesi Hastanesi — Elâzığ, Turkey (Türkiye) (enrolling)
• Istanbul Universitesi Cerrahpasa Tip Fakultesi — Istanbul, Turkey (Türkiye) (enrolling)
• Marmara Universitesi Tip Fakultesi Hastanesi — Istanbul, Turkey (Türkiye) (enrolling)
• Ege Universitesi Tip Fakultesi Hastanesi — Izmir, Turkey (Türkiye) (enrolling)
• Erciyes Universitesi Tip Fakultesi Hastanesi — Kayseri, Turkey (Türkiye) (enrolling)
• Hospital Raja Perempuan Zainab II — Kota Bharu, Kelantan, Malaysia
• Hospital Wanita Dan Kanak-Kanak Kuala Lumpur — Kuala Lumpur, Kuala Lumpur, Malaysia
• Hospital TuanKu Jaafar — Seremban, Negeri Sembilan, Malaysia
• SBHI Pediatrics city clinical hospital of Saint Vladimir — Moscow, Russia
• SBHI Children's City Multidisciplinary Clinical Specialized Center of High Medical Technologies — Saint Petersburg, Russia
• State Budgetary Healthcare Institution Samara Regional Clinical Hospital na V D Seredavin — Samara, Russia

Full record on ClinicalTrials.gov

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