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Phase 3 Evaluation of Etelcalcetide for Secondary Hyperparathyroidism in Pediatric Patients with Chronic Kidney Disease on Hemodialysis

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What is this study about?

This clinical trial is focused on studying secondary hyperparathyroidism in children and adolescents who have chronic kidney disease and are receiving regular hemodialysis. The treatment being tested is called etelcalcetide, which is also known by its code name AMG 416. Etelcalcetide is a medication that helps to reduce the levels of a hormone called parathyroid hormone (PTH) in the body. This hormone can become too high in people with secondary hyperparathyroidism, especially those with chronic kidney disease.

The purpose of the study is to see how effective etelcalcetide is in lowering PTH levels in children aged 2 to 18 years who are undergoing hemodialysis. Participants in the study will receive etelcalcetide as a solution for injection. The study will follow a specific plan where the dose of the medication may be adjusted over time to find the most effective amount for each participant. The study will last for a period of up to 26 weeks, during which the participants will be closely monitored to assess the effects of the treatment.

Throughout the study, researchers will collect information on how the medication affects PTH levels, as well as other important factors like calcium and phosphorus levels in the blood. The safety of etelcalcetide will also be evaluated to ensure it is well-tolerated by the participants. This study aims to provide valuable information on the use of etelcalcetide in managing secondary hyperparathyroidism in young patients with chronic kidney disease.

Who Can Join the Study?

  • The child must be between 2 and 17 years old at the time they join the study.
  • A parent or legal guardian must give permission for the child to participate, and the child must also agree to take part.
  • The child must have chronic kidney disease, which is a long-term condition where the kidneys do not work as well as they should.
  • The child must have secondary hyperparathyroidism, a condition where the parathyroid glands (small glands in the neck) become overactive, and this must not be caused by a lack of vitamin D.
  • The child must be receiving hemodialysis or hemodiafiltration, which are types of blood cleaning treatments, at least once a week.
  • The child’s serum calcium (the amount of calcium in the blood) must be at least 9.0 mg/dL during the initial testing.
  • The dialysate calcium level (the amount of calcium in the fluid used during dialysis treatment) must be at least 2.5 mEq/L and must stay at this level for at least one month before and during the study.
  • The child’s intact parathyroid hormone (iPTH) levels, which are measured in the blood, must have an average of more than 300 pg/mL based on two separate tests taken within two weeks of joining.
  • The child’s target dry weight (the ideal weight for the patient after fluid is removed during dialysis) must be at least 7 kg.
  • If the child is taking vitamin D sterols, phosphate binders (medicines used to control phosphate levels), or calcium supplements, their doses must not have changed by more than 50% in the two weeks before testing, and the doses must remain stable during the study.

Who Cannot Join the Study?

  • A history of certain heart rhythm problems, such as congenital long QT syndrome (a condition where the heart’s electrical system takes too long to recharge), second or third degree heart block (interference with the heart’s electrical signals), or ventricular tachyarrhythmias (fast, irregular heartbeats starting in the lower chambers of the heart).
  • Having used the study drug, etelcalcetide, within the last 6 months.
  • Taking any herbal medicines (such as St. John’s wort), vitamins, or supplements within 30 days of starting the study, unless specifically approved by the medical team.
  • Being pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study and for 3 months after the last dose.
  • Being currently enrolled in another study testing a different investigational drug or device (a medical product being tested for the first time), or having finished such a study less than 30 days ago.
  • Having previously participated in this specific study.
  • Having abnormal laboratory test results, such as serum transaminase levels (enzymes in the blood that can indicate liver health) that are more than 1.5 times the normal limit.
  • Having a corrected QT interval (a measurement of the time it takes for the heart muscle to recharge between beats) that is longer than 500 milliseconds, or between 450 and 500 milliseconds unless a pediatric cardiologist (a heart doctor for children) gives permission.
  • Having a significant abnormality on an electrocardiogram (ECG), which is a test that records the electrical activity of the heart, such as an unstable arrhythmia (an irregular heartbeat).
  • Having anemia (a condition where there are not enough healthy red blood cells) that makes frequent blood draws unsafe.
  • Experiencing new or worsening seizures (sudden, uncontrolled electrical disturbances in the brain).
  • Female participants of childbearing age who are unwilling to use a highly effective form of contraception (methods to prevent pregnancy) during the study and for 3 months after.
  • Taking anti-convulsant medication (medicine used to prevent seizures) unless the dose has been stable for at least 3 months.
  • Having a parathyroidectomy (surgery to remove the parathyroid glands) scheduled or planned during the study.
  • Having a known sensitivity or allergy to etelcalcetide or any of the other ingredients used in the medicine.
  • Being unlikely to attend all scheduled study visits or follow all the required study rules.
  • Having any other significant medical condition or disease that, in the doctor’s opinion, could make participation unsafe or interfere with the study results.
  • A history of unstable chronic heart failure (a long-term condition where the heart cannot pump blood effectively) within the last year.
  • Using certain over-the-counter or prescription medications within 14 days of starting the study that are not related to kidney disease, unless approved by the medical team.
  • Having a kidney transplant scheduled during the study period.
  • Having had a parathyroidectomy within the last 6 months.
  • Having a current malignancy (cancer) or a history of cancer, except for certain types of skin cancer.
  • Taking medications that might change the QTc (the heart’s electrical recharge time), such as certain antibiotics or heart medicines.
  • Having used cinacalcet (a medication used to control parathyroid hormone) within 30 days before or during the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Universitaetsklinikum Heidelberg AöR Heidelberg Germany

Other Sites

Site Name City Country Status
Azienda Ospedaliera Universitaria Meyer IRCCS Florence Italy
Universitair Ziekenhuis Gent Gent Belgium
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
Uniwersytecki Szpital Dzieciecy W Krakowie Cracow Poland
Athens General Children’s Hospital Panagioti And Aglaia Kyriakou Athens Greece
Virgen del Rocío University Hospital Sevilla Spain
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Uihljimalh Meryyfw Cdhuhd Huoixevastnayzbcg Hamburg Germany
Uabxfgjgcl Hhmhsyiy Czohxhw Cologne Germany
Fzhnwbub nvucbarzm Mabzn a Hrqrubv Prague Czechia
Hmigjehr Vviw docowixj Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
20.12.2019
Czechia Czechia
Recruiting
20.12.2019
Germany Germany
Recruiting
20.12.2019
Greece Greece
Recruiting
20.12.2019
Italy Italy
Not recruiting
20.12.2019
Poland Poland
Not recruiting
20.12.2019
Portugal Portugal
Recruiting
20.12.2019
Spain Spain
Recruiting
20.12.2019

Trial locations

Etelcalcetide is a medication given through an IV injection to help lower high levels of parathyroid hormone in children and adolescents who have kidney disease and undergo regular dialysis treatments.

Investigated diseases:

Secondary hyperparathyroidism – This condition occurs when the parathyroid glands produce too much parathyroid hormone. It is often a reaction to other health issues, such as chronic kidney disease, which disrupts the body’s mineral balance. As the kidneys lose their ability to function properly, levels of calcium and phosphorus in the blood become unbalanced. This imbalance signals the parathyroid glands to work harder to maintain stability. Over time, the continuous overproduction of the hormone can lead to changes in bone density and mineral levels.

Trial ID:
2023-506471-10-00
Protocol code:
20170724
NCT ID:
NCT03969329
Trial Phase:
Therapeutic confirmatory (Phase III)

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