Hyperparathyroidism Clinical Trials

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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Biological
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 17
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Service de Pédiatrie CHU de Bordeaux
RECRUITING
Bordeaux
Hôpital Femme Mère Enfant
RECRUITING
Bron
Service de pédiatrie multidisciplinaire CHU de Montpellier
RECRUITING
Montpellier
Unité de néphrologie pédiatrique, Hôpital Archet 2, CHU de Nice
RECRUITING
Nice
Service de Néphrologie - Transplantation - Hémodialyse pédiatrique Hôpital Robert Debré
RECRUITING
Paris
Service de Néphrologie pédiatrique Hôpital Necker Enfants Malades
RECRUITING
Paris
Service de pédiatrie 1 CHU Hautepierre
RECRUITING
Strasbourg
Contact Information
Primary
BACCHETTA Justine, MD
Justine.bacchetta@chu-lyon.fr
0033427856178
Backup
FLAMMIER Sacha, MD
Sacha.flammier@chu-lyon.fr
0033472681349
Time Frame
Start Date: 2026-04-29
Estimated Completion Date: 2028-08
Participants
Target number of participants: 20
Treatments
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
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov