NCT07007338 Calcium Isotope Ratios to Assess Calcium Bone Balance in Dialysis Children Receiving Cinacalcet
| NCT ID | NCT07007338 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Children Over 3 Undergoing Dialysis With Secondary Hyperparathyroidism |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-04-29 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2026-04-29 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
BACCHETTA Justine, MD
PRINCIPAL INVESTIGATOR
Hospices Civils de Lyon
Frequently Asked Questions
Who can join the NCT07007338 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 17 Years, studying Children Over 3 Undergoing Dialysis With Secondary Hyperparathyroidism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07007338 currently recruiting?
Yes, NCT07007338 is actively recruiting participants. Contact the research team at Justine.bacchetta@chu-lyon.fr for enrollment information.
Where is the NCT07007338 trial being conducted?
This trial is being conducted at Bordeaux, France, Bron, France, Montpellier, France, Nice, France and 3 additional locations.
Who is sponsoring the NCT07007338 clinical trial?
NCT07007338 is sponsored by Hospices Civils de Lyon. The principal investigator is BACCHETTA Justine, MD at Hospices Civils de Lyon. The trial plans to enroll 20 participants.