Clinical Trial

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

Study acronym: Cin-ca
Recruiting
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-05-28.
Status change: Not Yet Recruiting → Recruiting 2026-05-20
Trial Details
NCT Number NCT07007338
Lead Sponsor Hospices Civils de Lyon
Conditions Children Over 3 Undergoing Dialysis With Secondary Hyperparathyroidism
Enrollment 20 participants
Start Date 2026-04-29
Primary Completion 2028-08 (estimated)
Study Completion 2028-08 (estimated)
Updated on ClinicalTrials.gov 2026-05-22