RecruitingPhase 3NCT03969329

A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis

Phase 3, Single-arm, Open-label, Multidose, Titration, Pharmacokinetic, Pharmacodynamic, and Safety Study of Etelcalcetide in Children and Adolescents ≥ 2 to < 18 Years of Age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis

Sponsor

Amgen

Enrollment

24 participants

Start Date

Dec 20, 2019

Study Type

INTERVENTIONAL

Conditions

Secondary Hyperparathyroidism

Summary

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.

Eligibility

Min Age: 2 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a medication called etelcalcetide can safely lower dangerously high parathyroid hormone (PTH) levels in children with chronic kidney disease who are on dialysis. High PTH in kidney disease can damage bones and the heart. **You may be eligible if...** - Your child is between 2 and 17 years old - Your child has chronic kidney disease with overactive parathyroid glands (secondary hyperparathyroidism) - Your child is on hemodialysis or hemodiafiltration at least 3 times a week - PTH levels are above 300 pg/mL on two consecutive lab tests - Your child weighs at least 7 kg **You may NOT be eligible if...** - Your child is under 2 or 18 and older - PTH levels are not high enough - Your child does not meet dialysis frequency or weight requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEtelcalcetide

Etelcalcetide has been shown to be safe and efficacious in treating adult CKD patients with SHPT by simultaneously controlling iPTH, calcium (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.

Locations(23)

Universitair Ziekenhuis Gent

Ghent, Belgium

Fakultni nemocnice v Motole

Prague, Czechia

Hospices Civils de Lyon Hopital Femme Mere Enfant

Bron, France

Hopital Armand Trousseau

Paris, France

Kindernierenzentrum Bonn

Bonn, Germany

Universitaetsklinikum Koeln

Cologne, Germany

Universitaetsklinikum Hamburg Eppendorf

Hamburg, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Universitaetsklinikum Heidelberg, Zentrum fuer Kinder und Jugendmedizin

Heidelberg, Germany

General Children Hospital Panagioti and Aglaias Kyriakou

Athens, Greece

Ippokrateio General Hospital of Thessaloniki

Thessaloniki, Greece

Semmelweis Egyetem

Budapest, Hungary

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar

Szeged, Hungary

Azienda Ospedaliera Universitaria Meyer

Florence, Italy

Childrens Hospital, Affiliate of Vilnius University Hospital Santaros Klinikos

Vilinus, Lithuania

Uniwersytecki Szpital Dzieciecy w Krakowie

Krakow, Poland

Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio

Porto, Portugal

Hospital Universitario Virgen del Rocio

Seville, Andalusia, Spain

Hospital Universitari Vall d Hebron

Barcelona, Catalonia, Spain

Royal Hospital for Sick Children

Glasgow, United Kingdom

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Great Ormond Street Hospital for Children

London, United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT03969329

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