Clinical trial NCT07007338: Calcium Isotope Ratios to Assess Calcium Bone Balance in Dialysis Children Receiving Cinacalcet
Official title: Calcium Isotope Ratios to Assess Calcium Bone Balance in Dialysis Children Receiving Cinacalcet - The Cin-Ca Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Children Over 3 Undergoing Dialysis With Secondary Hyperparathyroidism
Keywords: CKD-MBD
children
secondary hyperparathyroism
Cinacalcet
dialysis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 20
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will involve children above 3 years of age on maintenance dialysis (hemodialysis, hemodiafiltration, peritoneal dialysis) who begin treatment with cinacalcet.

Brief summary: 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 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.


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

Primary outcomes:
measure: value of isotope ratios of calcium (44/42 Ca) in blood
timeFrame: Baseline / 3 months treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Service de Pédiatrie CHU de Bordeaux
city: Bron
country: France
facility: Hôpital Femme Mère Enfant
city: Montpellier
country: France
facility: Service de pédiatrie multidisciplinaire CHU de Montpellier
city: Nice
country: France
facility: Unité de néphrologie pédiatrique, Hôpital Archet 2, CHU de Nice
city: Paris
country: France
facility: Service de Néphrologie pédiatrique Hôpital Necker Enfants Malades
city: Paris
country: France
facility: Service de Néphrologie - Transplantation - Hémodialyse pédiatrique Hôpital Robert Debré
city: Strasbourg
country: France
facility: Service de pédiatrie 1 CHU Hautepierre
Study officials:
affiliation: Hospices Civils de Lyon
name: BACCHETTA Justine, MD
role: PRINCIPAL_INVESTIGATOR
References: