Actively Recruiting
A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Led by Amgen · Updated on 2026-02-27
56
Participants Needed
43
Research Sites
509 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase 3 trial of etelcalcetide in pediatric participants with secondary hyperparathyroidism (SHPT) and chronic kidney disease (CKD) on hemodialysis.
CONDITIONS
Official 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 and currently on hemodialysis
- Mean of two consecutive central lab iPTH values at or above 300 pg/mL during screening
- Serum corrected calcium 9.6 mg/dL or higher for ages 28 days to under 2 years, or 9.0 mg/dL or higher for ages 2 years and older during screening
- Dialysate calcium level 2.5 mEq/L or higher for at least 4 weeks before screening and during the trial
- Stable doses (no more than 50% change) of active vitamin D sterols, phosphate binders, or calcium supplements for 2 weeks before screening
- Secondary hyperparathyroidism not caused by vitamin D deficiency as assessed by 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 interval conditions
- Planned or scheduled parathyroidectomy or kidney transplant during the trial
- Parathyroidectomy within 6 months before randomization
- History of malignancy in the last 5 years except certain skin, cervical, or breast cancers
- Use of medications that may prolong QT interval unless approved with extra monitoring
- Use of cinacalcet within 30 days before screening and randomization
- Use of etelcalcetide within 6 months before screening and randomization
- Use of herbal medicines, vitamins, or supplements within 30 days before randomization without documented review
- Use of non-established medications for renal disease within 14 days or 5 half-lives before randomization without documented review
- Participation in another investigational drug or device trial currently or within 30 days
- Significant lab abnormalities such as elevated liver enzymes or prolonged QTc on ECG
- New or worsening seizure disorder within 60 days before enrollment
- Premature birth under 36 weeks gestational age in participants aged 28 days to 6 months
- Female participants who are pregnant, breastfeeding, or unwilling to use effective contraception during and 3 months after treatment
- Known allergy to etelcalcetide or its components
- Likely inability to complete study visits or comply with procedures
- Any other significant medical condition posing risk or interfering with study per investigator
- Previous participation in this trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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