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

NCT03633708 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 201403152017-002411-34
• Study Type: interventional
• Target: 56
• Locations: 10 countries
• Sites: 43

Brief Summary

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

Conditions

Chronic Kidney Disease; Secondary Hyperparathyroidism

Keywords

sHPT; CKD; pediatric; Secondary Hyperparathyroidism; Chronic Kidney disease

Outcome Measures

Primary Outcomes (2)

• 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).

  Baseline and Weeks 20-27

• 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).

  Baseline and Weeks 20-27

Secondary Outcomes (17)

• Maximum Serum Concentration (Cmax) of Etelcalcetide

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

• Minimum Serum Concentration (Cmin) of Etelcalcetide

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

• Number of Participants who Experienced Adverse Events (AEs)

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

• Frequency of Hypocalcemia

  Up to approximately 30 Weeks

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

  Up to approximately 30 Weeks

Study Arms (2)

Etelcalcetide

EXPERIMENTAL

Participants are randomized in a 5:1 ratio to receive etelcalcetide in addition to standard of care versus standard of care alone.

Drug: Etelcalcetide; Other: Standard of Care

Standard of Care

ACTIVE COMPARATOR

Participants are randomized in a 5:1 ratio to receive etelcalcetide in addition to standard of care versus standard of care alone.

Other: Standard of Care

Interventions

Standard of Care OTHER

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

Etelcalcetide; Standard of Care

Etelcalcetide DRUG

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

Also known as: Parsabiv

Etelcalcetide

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Amgen: lead

Study Sites (43)

Childrens Hospital of Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

Childrens Hospital Colorado

Aurora, Colorado, 80045, United States

TERMINATED

Childrens Mercy Hospital

Kansas City, Missouri, 64108, United States

RECRUITING

Mount Sinai Kidney Center - B1 Renal Treatment

New York, New York, 10029, United States

COMPLETED

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229, United States

COMPLETED

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

The Childrens Hospital at Oklahoma University Medical Center

Oklahoma City, Oklahoma, 73104, United States

COMPLETED

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Childrens Medical Center Dallas

Dallas, Texas, 75390, United States

TERMINATED

Primary Childrens Hospital Outpatient Services

Salt Lake City, Utah, 84113, United States

RECRUITING

Fresenius Escobar

Belén de Escobar, Buenos Aires, B1625DUG, Argentina

TERMINATED

Hospital Italiano

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

RECRUITING

Centro Infantil Del Rinon

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

RECRUITING

Manipal Hospital

Bangalore, Karnataka, 560 017, India

ACTIVE NOT RECRUITING

KLES Dr Prabhakar Kore Hospital and Medical Research Centre

Belagavi, Karnataka, 590010, India

ACTIVE NOT RECRUITING

Fortis Flt Lt Rajan Dhall Hospital

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

ACTIVE NOT RECRUITING

All India Institute of Medical Sciences

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

ACTIVE NOT RECRUITING

Sir Ganga Ram Hospital

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

ACTIVE NOT RECRUITING

NRS Medical College and Hospital

Kolkata, West Bengal, 700014, India

ACTIVE NOT RECRUITING

Hospital Raja Perempuan Zainab II

Kota Bharu, Kelantan, 15586, Malaysia

TERMINATED

Hospital Wanita Dan Kanak-Kanak Kuala Lumpur

Kuala Lumpur, Kuala Lumpur, 50300, Malaysia

TERMINATED

Hospital TuanKu Jaafar

Seremban, Negeri Sembilan, 70300, Malaysia

TERMINATED

SBHI Pediatrics city clinical hospital of Saint Vladimir

Moscow, 107014, Russia

TERMINATED

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

Saint Petersburg, 198205, Russia

COMPLETED

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

Samara, 443095, Russia

TERMINATED

National University Hospital

Singapore, 119074, Singapore

RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

TERMINATED

Seoul National University Hospital

Seoul, 110-744, South Korea

TERMINATED

Pusan National University Yangsan Hospital

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

TERMINATED

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

TERMINATED

National Cheng Kung University Hospital

Tainan, 70403, Taiwan

TERMINATED

National Taiwan University Hospital

Taipei, 10041, Taiwan

RECRUITING

Linkou Chang Gung Memorial Hospital

Taoyuan District, 33305, Taiwan

RECRUITING

Hacettepe Universitesi Tip Fakultesi Hastanesi

Ankara, 06230, Turkey (Türkiye)

RECRUITING

Baskent Universitesi Ankara Hastanesi

Ankara, 06490, Turkey (Türkiye)

RECRUITING

Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi

Ankara, 06500, Turkey (Türkiye)

RECRUITING

Ankara Bilkent Sehir Hastanesi

Ankara, 06800, Turkey (Türkiye)

RECRUITING

Firat Universitesi Tip Fakultesi Hastanesi

Elâzığ, 23200, Turkey (Türkiye)

RECRUITING

Istanbul Universitesi Cerrahpasa Tip Fakultesi

Istanbul, 34098, Turkey (Türkiye)

RECRUITING

Marmara Universitesi Tip Fakultesi Hastanesi

Istanbul, 34890, Turkey (Türkiye)

RECRUITING

Ege Universitesi Tip Fakultesi Hastanesi

Izmir, 35040, Turkey (Türkiye)

RECRUITING

Erciyes Universitesi Tip Fakultesi Hastanesi

Kayseri, 38039, Turkey (Türkiye)

RECRUITING

National Childrens Specializated Hospital Okhmadit

Kyiv, 01135, Ukraine

TERMINATED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Hyperparathyroidism, Secondary; Renal Insufficiency, Chronic

Interventions

etelcalcetide hydrochloride; Standard of Care

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 16, 2018
• Study Start: April 29, 2019
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2029
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this trial will be considered beginning 18 months after the trial has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this trial.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen trial/trials in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.

Locations

UA (1); KR (3); AR (3); MY (3); IN (6); TW (4); US (10); RU (3); SG (1); TU (9)