Recruiting NCT07007338

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

— Observational Children Over 3 Undergoing Dialysis With Secondary Hyperparathyroidism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Supplementary blood samples and urines samples.
Who it may be relevant to: Registry conditions: Children Over 3 Undergoing Dialysis With Secondary Hyperparathyroidism. Basic parameters: 3 years — 17 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: France
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Calcium Isotope Ratios to Assess Calcium Bone Balance in Dialysis Children Receiving Cinacalcet - The Cin-Ca Study

Overview

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.

Interventions

Biological Supplementary blood samples and urines samples
Supplementary blood and urines samples realised during routine visits

Primary outcome measures

value of isotope ratios of calcium (44/42 Ca) in blood [Time frame: Baseline / 3 months treatment]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

France · 7 centers

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

Identifiers

NCT: NCT07007338 · 69HCL24_1148

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗