Actively Recruiting
Phase 3 Study of Etelcalcetide in Children and Adolescents Aged 2 to Under 18 With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Led by Amgen · Updated on 2026-03-23
24
Participants Needed
23
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of etelcalcetide to treat secondary hyperparathyroidism (SHPT) in children and adolescents aged 2 to under 18 years who have chronic kidney disease (CKD) and are on hemodialysis. This phase 3 study aims to assess the drug's effectiveness, safety, how it is processed by the body (pharmacokinetics), and how it affects the body (pharmacodynamics) in this pediatric population. Participants will receive etelcalcetide alongside their standard care. The treatment involves multiple doses with titration to find the right dosage. The study is open-label and single-arm, meaning all participants receive the medication and are monitored over time. The trial includes treatment periods lasting up to 31 weeks. During the study, participants will undergo regular assessments including blood tests to measure changes in parathyroid hormone levels, calcium, and phosphorus. Researchers will monitor drug levels in the blood before and after dialysis sessions, track any side effects, and evaluate safety. The main outcome is the percent change in intact parathyroid hormone from baseline between weeks 20 to 26. The total participation time varies but includes ongoing monitoring throughout the treatment period.
CONDITIONS
Brief Title
A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant's legally acceptable representative has provided informed consent and the participant has given assent as per local regulations.
- Male or female participants aged 2 to under 18 years at enrollment.
- Targeted dry weight of at least 7 kg at screening.
- Diagnosed with chronic kidney disease and secondary hyperparathyroidism undergoing hemodialysis or hemodiafiltration three or four times weekly for at least 1 month.
- Mean of two consecutive intact parathyroid hormone (iPTH) values greater than 300 pg/mL during screening.
- Serum corrected calcium level of 9.0 mg/dL or higher at screening.
- Dialysate calcium level of at least 2.5 mEq/L for one month prior to screening and throughout the trial.
- Stable doses of active vitamin D sterols, phosphate binders, and calcium supplements with no more than 50% dose changes within 2 weeks before screening and expected stability during the trial.
- Secondary hyperparathyroidism not caused by vitamin D deficiency per investigator assessment.
You will not qualify if you...
- History of congenital long QT syndrome, advanced heart block, ventricular tachyarrhythmias, symptomatic ventricular dysrhythmias, or prolonged QT interval conditions.
- Planned or recent parathyroidectomy or kidney transplant during the trial period.
- Current or recent malignancy except non-melanoma skin cancer within 5 years.
- Use of medications that prolong QTc interval unless approved with monitoring.
- Recent use of cinacalcet or etelcalcetide within specified timeframes before screening.
- Use of herbal medicines, vitamins, or supplements within 30 days prior to enrollment without review.
- Participation in another investigational drug or device trial within 30 days before enrollment.
- Significant laboratory abnormalities including elevated liver enzymes or prolonged QT interval.
- New or worsening seizure disorder within 3 months prior to screening.
- Female participants who are pregnant, breastfeeding, or unwilling to use effective contraception during and after treatment.
- Known sensitivity to etelcalcetide or its components.
- Inability to complete trial visits or comply with procedures.
- History of unstable chronic heart failure within 1 year prior to screening.
- Anemia preventing safe blood draws.
- Previous participation in this trial or prior treatment with etelcalcetide as specified.
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 31 weeks
Participants receive etelcalcetide in addition to their standard hemodialysis care to manage secondary hyperparathyroidism.
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
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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