Taking people in FranceNo phase

Checking bone calcium balance in dialysis children taking cinacalcet

Studies calcium levels in blood and urine of dialysis children with high parathyroid hormone.

Key facts

Who runs it: Hospices Civils de Lyon
Where: Bordeaux, Bron, Montpellier, Nice, Paris, and Strasbourg, FranceSee the 7 sites
Trial code: NCT07007338
Registry title: Calcium Isotope Ratios to Assess Calcium Bone Balance in Dialysis Children Receiving Cinacalcet
Status: Recruiting
People taking part: 20 people, planned
Started: 29 Apr 2026
Expected to end: Aug 2028
Type of study: Observational
Treatments tested: Supplementary blood samples and urines samples
Record updated: 22 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children aged 3 to 17 who are on long-term dialysis and are starting cinacalcet for high parathyroid hormone levels.

Age: 3 to 17 years
Sex: All sexes can join.
Disease stage: On long-term dialysis (hemodialysis, hemodiafiltration or peritoneal dialysis), with secondary hyperparathyroidism. Normal QTc interval on the heart tracing (electrocardiogram), total blood calcium above 2.40 mmol/L, and hemoglobin above 8g/dl.
Earlier treatment: Children start cinacalcet as set by the 2019 European guidelines and the treating doctor. Children who had cinacalcet in the 3 months before joining cannot join.
Biomarker or test result: Normal QTc interval on electrocardiogram; total serum calcium >2.40 mmol/L; hemoglobin > 8g/dl.

Main reasons for not taking part

Weight under 12 kg (26 lb)
Had cinacalcet in the 3 months before joining
Taking part in other interventional research with an exclusion period still running
Deprived of liberty by a judicial or administrative decision
Under psychiatric care

This trial only enrols participants on dialysis. The registry sentence this rests on: On maintenance dialysis : hemodialysis, hemodiafiltration, peritoneal dialysis

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

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

Who cannot take part

Patients who received cinacalcet with 3 months prior inclusion
Persons under psychiatric care
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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 3 and 17 years old?

Where in France

Service de Pédiatrie CHU de BordeauxBordeaux, FranceContact: MADDEN Iona, MDTaking people
Hôpital Femme Mère EnfantBron, FranceContact: BACCHETTA Justine, MDTaking people
Service de pédiatrie multidisciplinaire CHU de MontpellierMontpellier, FranceContact: FILA Marc, MDTaking people
Unité de néphrologie pédiatrique, Hôpital Archet 2, CHU de NiceNice, FranceContact: BERNARDOR Julie, MDTaking people
Service de Néphrologie - Transplantation - Hémodialyse pédiatrique Hôpital Robert DebréParis, FranceContact: HOGAN Julien, MDTaking people
Service de Néphrologie pédiatrique Hôpital Necker Enfants MaladesParis, FranceContact: ULINSKI Tim, MDTaking people
Service de pédiatrie 1 CHU HautepierreStrasbourg, FranceContact: ZALOSZYC Ariane, MDTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The group in the trial

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
Treatment: Supplementary blood samples and urines samples