RecruitingOBSERVATIONAL

Calcium Isotope Ratios to Assess Calcium Bone Balance in Dialysis Children Receiving Cinacalcet

This study is for children aged 3 to 17 who are on dialysis because of kidney problems and have a condition called secondary hyperparathyroidism. This condition causes calcium and bone issues. Researchers want to understand if a medicine called cinacalcet helps improve bone health in these children. Cinacalcet is already used to lower a hormone that can damage bones. The study will use a new, non-invasive blood test to measure tiny changes in calcium in the body, which can show how bones are being affected. The goal is to ensure children with kidney disease get the best possible treatment to keep their bones strong and healthy.

At a glance

Status

Recruiting

Sponsor

Hospices Civils de Lyon

Enrolment target

Start

29 Apr 2026

Estimated completion

01 Aug 2028

Children Over 3 Undergoing Dialysis With Secondary Hyperparathyroidism

What is this study about?

When children have serious kidney problems and need dialysis, their bodies can struggle to manage calcium and bone health properly. This can lead to a condition called secondary hyperparathyroidism, where a hormone level gets too high, potentially harming their bones. Doctors work hard to control this by looking at how much calcium children get, managing other minerals, and sometimes using special medicines.

One of these medicines is called cinacalcet. It's been approved for use in Europe since 2017 for children over 3 who are on dialysis and have this bone condition. It works by lowering the hormone levels that can cause problems. In adults, cinacalcet has shown good results not just for hormone levels, but also for calcium balance, and it might even help protect against damage to blood vessels and improve bone health. This study wants to find out if it has similar positive effects on bone health in children.

The study will use a new and clever way to check bone health. It involves taking blood samples and looking at tiny differences in calcium in the body, almost like a special fingerprint for calcium. This helps doctors see if cinacalcet is actually making a positive difference to how calcium is used in the bones, which is really important for children growing up with kidney disease. The findings from this study could help doctors make better decisions about how to treat children in the future to keep their bones as healthy as possible.

Key takeaways

The study is for children aged 3-17 on dialysis with a bone-related condition.
It aims to understand how cinacalcet, a common medicine, affects bone health.
A new, non-invasive blood test will be used to check calcium balance in bones.
Children will receive their standard medical care, with extra blood and urine samples.
The findings could help improve future treatments for children with kidney disease.

Who may be eligible?

This study is looking for children aged 3 to 17 years old who are currently receiving dialysis treatment, whether it's hemodialysis, hemodiafiltration, or peritoneal dialysis. To be considered, your child must also be starting treatment with cinacalcet based on current medical guidelines, and their doctor needs to agree it's the right choice for them. They will also check if your child's heart rhythm is normal and if their blood calcium and haemoglobin levels are within a healthy range.

There are also some reasons why a child might not be able to join the study. These include if a child weighs less than 12 kg, or if they have already taken cinacalcet within the last three months. Children who are already taking part in another research study that has an overlap period, or those under certain legal or medical circumstances, would also not be able to participate. Your permission as a parent or legal guardian is essential for your child to join.

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 3 and 17 years old?
Is your child currently receiving dialysis treatment?
Is your child just starting or about to start treatment with cinacalcet?
Does your child weigh at least 12 kg (about 2 stone)?
Has your child not taken cinacalcet in the last three months?
Are you, as a parent or guardian, happy to give your permission?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will receive their usual cinacalcet treatment as prescribed by their doctor. The main difference they will experience is providing some extra blood samples and urine samples during their regular hospital visits. These samples will be used to perform the special calcium isotope test, which helps the researchers understand how cinacalcet is affecting their bones. The study doesn't say how many extra samples will be needed or over what period, but it's important to remember that these would be taken alongside their routine tests. There is no new medication being given specifically for the study; it's about observing the effects of a treatment your child would already be having.

Potential risks and benefits

Taking part in this study could help us understand more about how cinacalcet affects bone health in children with kidney disease, which might lead to better treatments for other children in the future. There are no direct medical benefits to your child from taking part, as they will be receiving the treatment their doctor would prescribe anyway. The main risk involves the extra blood samples, which may cause some temporary discomfort. You can choose to withdraw your child from the study at any time, for any reason, without it affecting their medical care.

Locations (7)

Service de Pédiatrie CHU de Bordeaux
Verified postcode
Bordeaux, France· Recruiting
Hôpital Femme Mère Enfant
Verified postcode
Bron, France· Recruiting
Service de pédiatrie multidisciplinaire CHU de Montpellier
Verified postcode
Montpellier, France· Recruiting
Unité de néphrologie pédiatrique, Hôpital Archet 2, CHU de Nice
Verified postcode
Nice, France· Recruiting
Service de Néphrologie pédiatrique Hôpital Necker Enfants Malades
Verified postcode
Paris, France· Recruiting
Service de Néphrologie - Transplantation - Hémodialyse pédiatrique Hôpital Robert Debré
Verified postcode
Paris, France· Recruiting
Service de pédiatrie 1 CHU Hautepierre
Verified postcode
Strasbourg, France· Recruiting

Common questions

What is dialysis?

Dialysis is a medical treatment that filters and cleans the blood, doing the job that healthy kidneys usually do, when a person's own kidneys aren't working well enough.

What is secondary hyperparathyroidism?

This is a condition common in people with kidney disease where a gland in the neck, called the parathyroid gland, makes too much of a hormone. This can make calcium levels in the body unbalanced and affect bone health.

What is cinacalcet?

Cinacalcet is a medicine used to help lower the levels of the parathyroid hormone, which in turn can help balance calcium and phosphate levels and improve bone health in people with kidney disease.

Will my child get a different treatment if they join?

No, your child will receive the cinacalcet treatment that their doctor has already decided is best for them. The study is about observing the effects of this treatment, not changing it.

What is a 'calcium isotope ratio' test?

It's a special blood test that looks at tiny, natural variations in calcium in the body. It helps researchers understand how calcium is moving in and out of bones, giving clues about bone health without needing an invasive procedure.

How to find out more

BACCHETTA Justine, MD

justine.bacchetta@chu-lyon.fr 0033427856178 Official trial record

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