Calcium Isotope Ratios to Assess Calcium Bone Balance in Dialysis Children Receiving Cinacalcet
NCT ID: NCT07007338
Last Updated: 2025-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
20 participants
OBSERVATIONAL
2025-09-30
2027-12-31
Brief Summary
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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 progression of cardiovascular calcifications.
Additionally, Professor Shroff has introduced a non-invasive method for assessing bone calcium status by analyzing stable calcium isotope ratios in blood. This method would allow to determine whether a treatment such as cinacalcet has a positive influence on bone calcium balance, a key element in the management of CKD-MBD.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Children above 3 years of age on maintenance dialysis who begin treatment with cinacalcet
Children above 3 years of age on maintenance dialysis (hemodialysis, hemodiafiltration, peritoneal dialysis) who begin treatment with cinacalcet because of secondary hyperparathyroism
Supplementary blood samples and urines samples
Supplementary blood and urines samples realised during routine visits
Interventions
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Supplementary blood samples and urines samples
Supplementary blood and urines samples realised during routine visits
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
3 Years
17 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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BACCHETTA Justine, MD
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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MADDEN Iona, MD
Role: primary
Other Identifiers
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69HCL24_1148
Identifier Type: -
Identifier Source: org_study_id
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