Actively Recruiting
Phase 3, Randomized, Open-label, Controlled Study of Etelcalcetide in Pediatric Participants 28 Days to Under 18 Years With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Led by Amgen · Updated on 2026-02-27
56
Participants Needed
43
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating etelcalcetide in children with secondary hyperparathyroidism (SHPT) who also have chronic kidney disease (CKD) and are receiving hemodialysis. SHPT is a serious condition that develops early in CKD and can cause bone and growth problems as well as increased cardiovascular risks in children on dialysis. This phase 3 trial aims to provide important safety and efficacy data for etelcalcetide in pediatric patients aged 28 days to under 18 years, addressing the limitations of current treatments like vitamin D sterols. Participants are randomly assigned in a 5:1 ratio to receive either etelcalcetide along with standard care or standard care alone. The standard care may include treatments such as vitamin D sterols, calcium supplements, or phosphate binders. The study involves multiple doses of etelcalcetide, with assessments conducted over weeks to monitor its effects on parathyroid hormone levels and mineral balance. During the study, participants will undergo regular evaluations including blood tests to measure intact parathyroid hormone, calcium, and phosphorus levels. Researchers will also monitor safety by tracking adverse events and changes in vital signs, growth, and development stages. The primary outcome focuses on the percentage of participants achieving a significant reduction in hormone levels over weeks 20 to 27. The trial includes careful monitoring throughout treatment and up to approximately 30 weeks after the last dose.
CONDITIONS
Brief Title
A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 28 days and under 18 years
- Dry weight of 7 kg or more at screening
- Diagnosed with chronic kidney disease and secondary hyperparathyroidism undergoing hemodialysis at screening
- Mean intact parathyroid hormone (iPTH) levels of 300 pg/mL or higher from two tests within 2 weeks before enrollment
- Serum corrected calcium of 9.0 mg/dL or higher for participants 2 years or older, or 9.6 mg/dL or higher for those between 28 days and under 2 years
- Dialysate calcium level of 2.5 mEq/L or higher for at least 4 weeks before and during the trial
- Stable doses of vitamin D sterols, phosphate binders, and calcium supplements within 2 weeks before screening
- Secondary hyperparathyroidism not caused by vitamin D deficiency, as assessed by the investigator
You will not qualify if you...
- History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrhythmias, or other prolonged QT conditions
- Planned parathyroidectomy or kidney transplant during the trial
- Parathyroidectomy within 6 months before randomization
- History of malignancy within 5 years, except certain skin or in situ cancers
- Use of medications that may prolong QT interval unless approved with extra monitoring
- Use of cinacalcet within 30 days before screening or etelcalcetide within 6 months before screening
- Use of herbal medicines, vitamins, or supplements within 30 days before randomization without review and approval
- Use of non-approved medications within 14 days before randomization without review and approval
- Participation in another investigational drug or device trial within 30 days before enrollment
- Significant lab abnormalities including liver enzymes over twice normal limits
- Corrected QT interval over 500 ms or 450 to 500 ms without special approval
- Clinically significant ECG abnormalities posing risk or interfering with the trial
- New or worsening seizure disorder within 60 days before enrollment
- Premature birth under 36 weeks gestational age for participants aged 28 days to 6 months
- Female participants who are pregnant, breastfeeding, or unwilling to use effective contraception
- Known sensitivity to etelcalcetide or its ingredients
- Inability to complete all trial visits or comply with procedures
- Other significant medical conditions judged by the investigator to pose risk or interfere with the trial
- Previous participation in this trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to approximately 30 weeks
Participants receive etelcalcetide in addition to standard of care or standard of care alone while undergoing hemodialysis to treat secondary hyperparathyroidism.
Weekly visits for dosing and assessments during treatment
Trial Site Locations
Total: 43 locations
1
Childrens Hospital of Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
2
Childrens Hospital Colorado
Aurora, Colorado, United States, 80045
Terminated
3
Childrens Mercy Hospital
Kansas City, Missouri, United States, 64108
Actively Recruiting
4
Mount Sinai Kidney Center - B1 Renal Treatment
New York, New York, United States, 10029
Completed
5
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Completed
6
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
7
The Childrens Hospital at Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States, 73104
Completed
8
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
9
Childrens Medical Center Dallas
Dallas, Texas, United States, 75390
Terminated
10
Primary Childrens Hospital Outpatient Services
Salt Lake City, Utah, United States, 84113
Actively Recruiting
11
Fresenius Escobar
Belen de Escobar, Buenos Aires, Argentina, B1625DUG
Terminated
12
Hospital Italiano
Cuidad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1199ABB
Actively Recruiting
13
Centro Infantil Del Rinon
San Miguel de Tucumán, Tucumán Province, Argentina, 4000
Actively Recruiting
14
Manipal Hospital
Bangalore, Karnataka, India, 560 017
Active, Not Recruiting
15
KLES Dr Prabhakar Kore Hospital and Medical Research Centre
Belagavi, Karnataka, India, 590010
Active, Not Recruiting
16
Fortis Flt Lt Rajan Dhall Hospital
New Delhi, National Capital Territory of Delhi, India, 110 070
Active, Not Recruiting
17
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India, 110029
Active, Not Recruiting
18
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, India, 110060
Active, Not Recruiting
19
NRS Medical College and Hospital
Kolkata, West Bengal, India, 700014
Active, Not Recruiting
20
Hospital Raja Perempuan Zainab II
Kota Bharu, Kelantan, Malaysia, 15586
Terminated
21
Hospital Wanita Dan Kanak-Kanak Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, Malaysia, 50300
Terminated
22
Hospital TuanKu Jaafar
Seremban, Negeri Sembilan, Malaysia, 70300
Terminated
23
SBHI Pediatrics city clinical hospital of Saint Vladimir
Moscow, Russia, 107014
Terminated
24
SBHI Children's City Multidisciplinary Clinical Specialized Center of High Medical Technologies
Saint Petersburg, Russia, 198205
Completed
25
State Budgetary Healthcare Institution Samara Regional Clinical Hospital na V D Seredavin
Samara, Russia, 443095
Terminated
26
National University Hospital
Singapore, Singapore, 119074
Actively Recruiting
27
Asan Medical Center
Seoul, South Korea, 05505
Terminated
28
Seoul National University Hospital
Seoul, South Korea, 110-744
Terminated
29
Pusan National University Yangsan Hospital
Yangsan-si, Gyeongsangnam-do, South Korea, 50612
Terminated
30
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan, 81362
Terminated
31
National Cheng Kung University Hospital
Tainan, Taiwan, 70403
Terminated
32
National Taiwan University Hospital
Taipei, Taiwan, 10041
Actively Recruiting
33
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan, 33305
Actively Recruiting
34
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, Turkey (Türkiye), 06230
Actively Recruiting
35
Baskent Universitesi Ankara Hastanesi
Ankara, Turkey (Türkiye), 06490
Actively Recruiting
36
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
Ankara, Turkey (Türkiye), 06500
Actively Recruiting
37
Ankara Bilkent Sehir Hastanesi
Ankara, Turkey (Türkiye), 06800
Actively Recruiting
38
Firat Universitesi Tip Fakultesi Hastanesi
Elâzığ, Turkey (Türkiye), 23200
Actively Recruiting
39
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, Turkey (Türkiye), 34098
Actively Recruiting
40
Marmara Universitesi Tip Fakultesi Hastanesi
Istanbul, Turkey (Türkiye), 34890
Actively Recruiting
41
Ege Universitesi Tip Fakultesi Hastanesi
Izmir, Turkey (Türkiye), 35040
Actively Recruiting
42
Erciyes Universitesi Tip Fakultesi Hastanesi
Kayseri, Turkey (Türkiye), 38039
Actively Recruiting
43
National Childrens Specializated Hospital Okhmadit
Kyiv, Ukraine, 01135
Terminated
Research Team
A
Amgen Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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