NCT07007338Recruiting
Calcium Isotope Ratios to Assess Calcium Bone Balance in Dialysis Children Receiving Cinacalcet
Calcium Isotope Ratios to Assess Calcium Bone Balance in Dialysis Children Receiving Cinacalcet - The Cin-Ca Study
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 20 (estimated)
- First submitted
- 28 May 2025
- Start date
- 29 Apr 2026
- Primary completion date
- 31 Aug 2028
- Lead sponsor
- Hospices Civils de Lyon
- Diseases
- Chronic kidney disease
- NCT number
- NCT07007338
What you commit to
- Study type: Observational
- Planned participants: 20
- From 29 Apr 2026 to the primary completion date, 31 Aug 2028
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who received cinacalcet with 3 months prior inclusion
Other illness
- Persons under psychiatric care
Other
- Children \< 12 kg
- Persons deprived of their liberty by a judicial or administrative decision
- 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
Who the study is looking for
- 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
Age in the registry: 3 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Service de Pédiatrie CHU de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Hôpital Femme Mère Enfant Coordinator of this site? Confirm its status | Bron | France | Recruiting |
| Service de pédiatrie multidisciplinaire CHU de Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| Unité de néphrologie pédiatrique, Hôpital Archet 2, CHU de Nice Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Service de Néphrologie - Transplantation - Hémodialyse pédiatrique Hôpital Robert Debré Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Service de Néphrologie pédiatrique Hôpital Necker Enfants Malades Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Service de pédiatrie 1 CHU Hautepierre Coordinator of this site? Confirm its status | Strasbourg | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.