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

Recruitingn/aAges 3 Years - 17 YearsAllHospices Civils de Lyon
NCT07007338 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Managing bone and mineral disorders associated with chronic kidney disease (CKD-MBD) in children is a complex task. Controlling parathyroid hormone (PTH) levels involves adjusting calcium intake, managing hyperphosphatemia, intensive dialysis, and considering specific therapies like active vitamin D analogues and cinacalcet. Cinacalcet, authorized in Europe since 2017 for children over 3 undergoing dialysis with secondary hyperparathyroidism (SHPT), has shown efficacy in reducing PTH levels. The 2019 guidelines call for its use with caution particularly to avoid hypocalcemia, in children with severe hyperparathyroidism despite optimized conventional treatments. In adults, cinacalcet has been found to reduce serum PTH, calcium, and phosphate levels, decrease the risk of vascular calcification, and have a positive effect on bone formation. This suggests that cinacalcet may slow the progr

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📋 Eligibility rules (as published)
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
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What it tests

  • Supplementary blood samples and urines samples
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Where

7 sites
Service de Pédiatrie CHU de Bordeaux
Bordeaux, France
Hôpital Femme Mère Enfant
Bron, France
Service de pédiatrie multidisciplinaire CHU de Montpellier
Montpellier, France
Unité de néphrologie pédiatrique, Hôpital Archet 2, CHU de Nice
Nice, France
Service de Néphrologie pédiatrique Hôpital Necker Enfants Malades
Paris, France
Service de Néphrologie - Transplantation - Hémodialyse pédiatrique Hôpital Robert Debré
Paris, France
Service de pédiatrie 1 CHU Hautepierre
Strasbourg, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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