RecruitingPHASE3INTERVENTIONAL

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

This important study is investigating a new medication, Etelcalcetide, for children and teenagers aged 2 to 17 years old. These young patients all have chronic kidney disease and are currently receiving dialysis treatment. The trial focuses on a common complication of kidney disease called secondary hyperparathyroidism, where the body's parathyroid glands produce too much hormone. Researchers want to understand if Etelcalcetide is effective at controlling this condition, how safe it is for children, and how it moves through and affects their bodies. This is a Phase 3 study, meaning it’s a later stage of research, usually involving a larger number of people to confirm earlier findings and gather more information before a medicine can be widely used.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Amgen

Enrolment target

Start

20 Dec 2019

Estimated completion

30 Jun 2027

Secondary Hyperparathyroidism

What is this study about?

This clinical trial is designed to investigate a treatment called Etelcalcetide for a condition known as secondary hyperparathyroidism in children and teenagers. This condition often develops in people, especially children, with chronic kidney disease who are receiving dialysis. When kidneys don't work properly, they can't balance certain chemicals in the body, leading the parathyroid glands (small glands in the neck) to become overactive and produce too much parathyroid hormone. This can cause problems with bones and overall health.

The main goal of this study is to see if Etelcalcetide can effectively help control this overactive parathyroid gland in young patients. Researchers will be carefully checking if the medicine reduces the high levels of parathyroid hormone and if it's safe for children to use. They will also look at how the medicine is absorbed and used by the body, and how the body reacts to it.

This is a 'Phase 3' study, which means the medicine has already been studied in smaller groups and shown some promise. This larger study aims to confirm those initial findings, gather more detailed information on its effectiveness and safety, and understand how best to use it in this specific group of patients before it can potentially become a widely available treatment option.

Key takeaways

This study is for children (2-17 years old) with kidney disease on dialysis.
It's testing a new medicine called Etelcalcetide for secondary hyperparathyroidism.
The goal is to see if Etelcalcetide is effective and safe.
It's a Phase 3 study, a later stage of research.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is specifically looking for children and teenagers aged between 2 and 17 years old. To be considered, they must have long-term kidney disease and be receiving regular dialysis treatment for at least one month. A key requirement is that they must also have been diagnosed with secondary hyperparathyroidism, which means their parathyroid hormone levels are above a certain level.

There are also some important medical checks required during the screening process, such as having certain calcium levels in their blood. If a child is currently taking vitamin D treatments, phosphate binders, or calcium supplements, their doses must have been stable for a certain period before joining the study and they would need to keep them stable throughout the trial, unless changes are specifically allowed by the study doctors.

For children too young to give their full consent, a parent or legal guardian must provide permission for them to join the study. The child themselves will also be asked for their agreement, known as 'assent', if they are old enough to understand what's involved, based on local UK guidelines.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child between 2 and 17 years old?
Does your child have long-term kidney disease and receive regular dialysis?
Has your child been diagnosed with secondary hyperparathyroidism?
Are your child's current medication doses (for vitamin D, phosphate, calcium) stable, or can they be kept stable?

Answer every question to see your result.

What does participation involve?

If your child is eligible for this study, their participation will involve regular visits to the clinic for medical assessments. These assessments will include blood tests to check their parathyroid hormone, calcium levels, and to see how the study medicine is affecting their body. They will be given the study medication, Etelcalcetide, according to a schedule. Throughout the study, doctors and nurses will closely monitor their health and any changes. The total duration of participation in the study would involve an initial screening period followed by the treatment phase. You will be given clear information about the exact schedule of visits and tests during the informed consent process.

Potential risks and benefits

Taking part in a clinical trial like this could offer potential benefits, such as receiving a new medication that might help manage secondary hyperparathyroidism better than current treatments. You would also be contributing to medical research that could help many other children in the future. However, there are potential risks, including side effects from the medication or discomfort from blood tests and clinic visits. All possible side effects and risks will be fully explained to you before you decide to take part. It's very important to remember that participation is completely voluntary, and you are free to withdraw your child from the study at any time, for any reason, without affecting their usual medical care.

Locations (23)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Universitair Ziekenhuis Gent
Verified postcode
Ghent, Belgium· Terminated
Fakultni nemocnice v Motole
Verified postcode
Prague, Czechia· Completed
Hospices Civils de Lyon Hopital Femme Mere Enfant
Verified postcode
Bron, France· Terminated
Hopital Armand Trousseau
Verified postcode
Paris, France· Completed
Kindernierenzentrum Bonn
Verified postcode
Bonn, Germany· Completed
Universitaetsklinikum Koeln
Verified postcode
Cologne, Germany· Recruiting
Universitaetsklinikum Hamburg Eppendorf
Verified postcode
Hamburg, Germany· Recruiting
Medizinische Hochschule Hannover
Verified postcode
Hanover, Germany· Completed
Universitaetsklinikum Heidelberg, Zentrum fuer Kinder und Jugendmedizin
Verified postcode
Heidelberg, Germany· Recruiting
General Children Hospital Panagioti and Aglaias Kyriakou
Verified postcode
Athens, Greece· Recruiting
Ippokrateio General Hospital of Thessaloniki
Verified postcode
Thessaloniki, Greece· Recruiting
Semmelweis Egyetem
Verified postcode
Budapest, Hungary· Terminated

Common questions

What is secondary hyperparathyroidism?

It's a condition where the parathyroid glands in your neck become overactive and make too much hormone, often caused by long-term kidney problems.

What is Etelcalcetide?

Etelcalcetide is the new medicine being tested in this study to help control the overactive parathyroid glands.

What does 'Phase 3 Study' mean?

It means the medicine has already been studied in smaller groups, and this larger study aims to confirm its effectiveness and safety before it can be widely used.

Will my child still receive their usual dialysis?

Yes, children in this study will continue to receive their regular dialysis treatments as their primary kidney care.

Who decides if my child can join the study?

Your child's doctor, along with the study team, will determine if they meet the specific requirements. If eligible, a parent or guardian must give consent, and the child will also be asked for their agreement if they are old enough to understand.

How to find out more

Amgen Call Center

medinfo@amgen.com 866-572-6436 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.