Actively Recruiting
A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis
Led by Amgen · Updated on 2026-03-23
24
Participants Needed
23
Research Sites
392 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in pediatric participants between ≥ 2 to \< 18 years of age, with chronic kidney disease (CKD) on hemodialysis.
CONDITIONS
Official Title
A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Legally acceptable representative has provided informed consent and participant has provided assent if required
- Male or female participants aged 2 to less than 18 years at enrollment
- Target dry weight of at least 7 kg at screening
- Diagnosed with chronic kidney disease and secondary hyperparathyroidism receiving hemodialysis/hemodiafiltration three or four times weekly for at least 1 month
- Mean of two consecutive iPTH values above 300 pg/mL during screening
- Serum corrected calcium level of 9.0 mg/dL or higher at screening
- Dialysate calcium level at least 2.5 mEq/L for at least 1 month before screening and during the trial
- Stable doses of active vitamin D sterols, phosphate binders, and calcium supplements within 2 weeks before screening and expected to remain stable except for protocol adjustments
- Secondary hyperparathyroidism not caused by vitamin D deficiency as assessed by investigator
You will not qualify if you...
- History of congenital long QT syndrome, advanced heart block, ventricular tachyarrhythmias, or conditions causing prolonged QT interval
- Planned or recent parathyroidectomy or kidney transplant during the trial
- Current or recent malignancy except non-melanoma skin cancer within 5 years
- Use of medications that may prolong QTc interval without medical monitor approval
- Use of cinacalcet therapy or prior etelcalcetide treatment within specified timeframes
- Use of herbal medicines, vitamins, or supplements within 30 days prior to enrollment without documented review
- Use of non-established medications for renal disease within 14 days prior to enrollment without documented review
- Participation in another investigational drug or device trial currently or within 30 days prior
- Significant abnormalities in liver enzymes or ECG during screening
- New or worsening seizure disorder within 3 months prior to screening or unstable anticonvulsant therapy
- Female participants who are pregnant, breastfeeding, or not using effective contraception
- Known sensitivity to etelcalcetide or its ingredients
- Likely inability to complete study visits or comply with procedures
- Other clinically significant disorders or conditions posing safety risks
- Anemia making blood draws inadvisable
- History of unstable chronic heart failure within 1 year prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 23 locations
1
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Terminated
2
Fakultni nemocnice v Motole
Prague, Czechia, 150 06
Completed
3
Hospices Civils de Lyon Hopital Femme Mere Enfant
Bron, France, 69677
Terminated
4
Hopital Armand Trousseau
Paris, France, 75012
Completed
5
Kindernierenzentrum Bonn
Bonn, Germany, 53127
Completed
6
Universitaetsklinikum Koeln
Cologne, Germany, 50937
Actively Recruiting
7
Universitaetsklinikum Hamburg Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
8
Medizinische Hochschule Hannover
Hanover, Germany, 30625
Completed
9
Universitaetsklinikum Heidelberg, Zentrum fuer Kinder und Jugendmedizin
Heidelberg, Germany, 69120
Actively Recruiting
10
General Children Hospital Panagioti and Aglaias Kyriakou
Athens, Greece, 11527
Actively Recruiting
11
Ippokrateio General Hospital of Thessaloniki
Thessaloniki, Greece, 54642
Actively Recruiting
12
Semmelweis Egyetem
Budapest, Hungary, 1083
Terminated
13
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar
Szeged, Hungary, 6720
Terminated
14
Azienda Ospedaliera Universitaria Meyer
Florence, Italy, 50139
Terminated
15
Childrens Hospital, Affiliate of Vilnius University Hospital Santaros Klinikos
Vilinus, Lithuania, 08406
Terminated
16
Uniwersytecki Szpital Dzieciecy w Krakowie
Krakow, Poland, 30-663
Terminated
17
Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio
Porto, Portugal, 4050-651
Actively Recruiting
18
Hospital Universitario Virgen del Rocio
Seville, Andalusia, Spain, 41013
Terminated
19
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, Spain, 08035
Actively Recruiting
20
Royal Hospital for Sick Children
Glasgow, United Kingdom, G51 4TF
Actively Recruiting
21
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom, LS1 3EX
Actively Recruiting
22
Great Ormond Street Hospital for Children
London, United Kingdom, WC1N 3JH
Terminated
23
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
Research Team
A
Amgen Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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