Calcium Isotope Ratios in Kids on Dialysis Receiving Cinacalcet
Official title: Calcium Isotope Ratios to Assess Calcium Bone Balance in Dialysis Children Receiving Cinacalcet - The Cin-Ca Study
Run by Hospices Civils de Lyon · NCT07007338 · Data updated 2026-11-12
This study tests how calcium isotope ratios relate to bone balance in children aged 3–17 who are on dialysis and starting cinacalcet for secondary hyperparathyroidism.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 3 Years to 17 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 7 sites (Bordeaux and 6 other locations) |
| Status | Recruiting |
| Started | April 29, 2026 |
| Main results expected | August 2028 |
| Study ends | August 2028 |
| Registry record updated | May 22, 2026 |
| Trial ID | NCT07007338 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 3 to 17 on maintenance dialysis who are starting cinacalcet per 2019 European guidelines and have no contraindications described in the criteria.
✕Probably not a fit
Children not responding to cinacalcet or not meeting the specific inclusion criteria may not experience direct benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates bone and mineral balance in pediatric dialysis patients who begin cinacalcet therapy. Researchers will collect supplementary blood and urine samples to analyze calcium isotope ratios and related markers. The aim is to understand how cinacalcet affects mineral metabolism and bone health in this population under standard clinical care. Participation is limited to children with appropriate calcium levels and QTc intervals, whose treatment is guided by European guidelines and their physicians. The study is conducted across multiple pediatric centers in France and involves non-invasive sample collection during routine care.
Why it matters
Potential benefit: Participants may gain closer monitoring of mineral metabolism and potential insights that could improve bone health management in the future.
How similar studies have gone: Previous adult and pediatric work suggests cinacalcet can modify mineral metabolism, but pediatric data on calcium isotope ratios are limited and exploratory.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Service de Pédiatrie CHU de Bordeaux
Bordeaux, France Recruiting -
Hôpital Femme Mère Enfant
Bron, France Recruiting -
Service de pédiatrie multidisciplinaire CHU de Montpellier
Montpellier, France Recruiting -
Unité de néphrologie pédiatrique, Hôpital Archet 2, CHU de Nice
Nice, France Recruiting -
Service de Néphrologie pédiatrique Hôpital Necker Enfants Malades
Paris, France Recruiting -
Service de Néphrologie - Transplantation - Hémodialyse pédiatrique Hôpital Robert Debré
Paris, France Recruiting
Show 1 more location
-
Service de pédiatrie 1 CHU Hautepierre
Strasbourg, France Recruiting
Study contacts
- Principal investigator: BACCHETTA Justine, MD — Hospices Civils de Lyon
- Study coordinator: BACCHETTA Justine, MD
- Email: Justine.bacchetta@chu-lyon.fr
- Phone: 0033427856178
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.