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

Launched by HOSPICES CIVILS DE LYON · May 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how well a medication called cinacalcet helps children aged 3 to 17 who are undergoing dialysis for kidney disease. These children often have a condition called secondary hyperparathyroidism, where their body produces too much parathyroid hormone (PTH), which can affect their bones and overall health. The trial aims to find out if cinacalcet can improve the balance of calcium in their bones by using a new, non-invasive blood test that measures calcium levels.

To participate, children must be on maintenance dialysis and starting cinacalcet treatment based on their doctor’s recommendation. They should also have a normal heart rhythm and meet certain health criteria. The trial has not started recruiting participants yet, but once it begins, families can expect to learn more about how this treatment may help manage bone health in kids with chronic kidney disease. It's important to note that there are specific rules about who can join the study to ensure everyone's safety and well-being.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Children from 3 to 17 years of age
• • On maintenance dialysis : hemodialysis, hemodiafiltration, peritoneal dialysis
• • Patient who begin treatment with cinacalcet based on the 2019 European guidelines and at the discretion of the treating physician
• • With normal QTc interval on electrocardiogram
• • With total serum calcium \>2.40 mmol/L
• • With heamoglobin \> 8g/dl
• • Non - opposition from parents/legal guardians
• Exclusion Criteria:
• • Children \< 12 kg
• • Persons deprived of their liberty by a judicial or administrative decision
• • Persons under psychiatric care
• • Persons admitted to a health or social institution for purposes other than research
• • Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
• • Persons participating in other interventional research with an exclusion period still in progress at pre-inclusion
• • Patients who received cinacalcet with 3 months prior inclusion