Children Over 3 Undergoing Dialysis With Secondary HyperparathyroidismCin-caNCT07007338
Calcium Isotope Ratios to Assess Calcium Bone Balance in Dialysis Children Receiving Cinacalcet
An observational study of Children Over 3 Undergoing Dialysis With Secondary Hyperparathyroidism, run by Hospices Civils de Lyon at 7 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Children Over 3 Undergoing Dialysis With Secondary Hyperparathyroidism
- What is being tested?
- Supplementary blood samples and urines samples
- How many people
- 20 participants
- Where
- 7 sitesFrance
- Study dates
- 29 Apr 2026to Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: This study will involve children above 3 years of age on maintenance dialysis (hemodialysis, hemodiafiltration, peritoneal dialysis) who begin treatment with cinacalcet.
Who may be able to join
- 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 join
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 7 recruiting
- Recruiting
Service de Pédiatrie CHU de Bordeaux
Bordeaux, 33000
MADDEN Iona, MD
- Recruiting
Hôpital Femme Mère Enfant
Bron, 69500
BACCHETTA Justine, MD, 0033427856178, Justine.bacchetta@chu-lyon.fr
- Recruiting
Service de pédiatrie multidisciplinaire CHU de Montpellier
Montpellier, 34295
FILA Marc, MD, m-fila@chu-montpellier.fr
- Recruiting
Unité de néphrologie pédiatrique, Hôpital Archet 2, CHU de Nice
Nice, 06202
BERNARDOR Julie, MD, bernardor.j@chu-nice.fr
- Recruiting
Service de Néphrologie pédiatrique Hôpital Necker Enfants Malades
Paris, 75012
ULINSKI Tim, MD, tim.ulinski@aphp.fr
- Recruiting
Service de Néphrologie - Transplantation - Hémodialyse pédiatrique Hôpital Robert Debré
Paris, 75019
HOGAN Julien, MD, Julien.hogan2@aphp.fr
- Recruiting
Service de pédiatrie 1 CHU Hautepierre
Strasbourg, 67000
ZALOSZYC Ariane, MD, ariane.zaloszyc@chru-strasbourg.fr
About this study
Official title: Calcium Isotope Ratios to Assess Calcium Bone Balance in Dialysis Children Receiving Cinacalcet - The Cin-Ca Study
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.
Read more
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.
- Being tested
- Supplementary blood samples and urines samples
- Keywords
- CKD-MBD, children, secondary hyperparathyroism, Cinacalcet, dialysis
- Medical subject headings
- Chronic Kidney Disease-Mineral and Bone Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplementary blood samples and urines samplesBiological
Supplementary blood and urines samples realised during routine visits
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Supplementary blood samples and urines samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
value of isotope ratios of calcium (44/42 Ca) in blood
value of 44/42 Ca ratio in patients at baseline and, three months after cinacalcet treatment
Measured: Baseline / 3 months treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start29 Apr 2026
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children Over 3 Undergoing Dialysis With Secondary HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BACCHETTA Justine, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007338
- Sponsor's protocol ID
- 69HCL24_1148
- Acronym
- Cin-ca
- Status last verified
- May 2026
- First submitted
- 28 May 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium Isotope Ratios to Assess Calcium Bone Balance in Dialysis Children Receiving Cinacalcet - The Cin-Ca Study
- ClinicalTrials.gov ID
- NCT07007338
- Acronym / sponsor ID
- Cin-ca / 69HCL24_1148
- Keywords
- CKD-MBD, children, secondary hyperparathyroism, Cinacalcet, dialysis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 29 Apr 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children above 3 years of age on maintenance dialysis who begin treatment with cinacalcet | – | Biological: Supplementary blood samples and urines samplesChildren above 3 years of age on maintenance dialysis (hemodialysis, hemodiafiltration, peritoneal dialysis) who begin treatment with cinacalcet because of secondary hyperparathyroism |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study will involve children above 3 years of age on maintenance dialysis (hemodialysis, hemodiafiltration, peritoneal dialysis) who begin treatment with cinacalcet.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supplementary blood samples and urines samplesSupplementary blood and urines samples realised during routine visits | Biological | Children above 3 years of age on maintenance dialysis who begin treatment with cinacalcet |
Primary outcome
value of isotope ratios of calcium (44/42 Ca) in blood
Time frame: Baseline / 3 months treatment
value of 44/42 Ca ratio in patients at baseline and, three months after cinacalcet treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BACCHETTA Justine, MD principal investigator
Hospices Civils de Lyon
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Children Over 3 Undergoing Dialysis With Secondary Hyperparathyroidism, run by Hospices Civils de Lyon at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BACCHETTA Justine, MD (0033427856178, Justine.bacchetta@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
value of isotope ratios of calcium (44/42 Ca) in blood (time frame: Baseline / 3 months treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.