NephrocalcinosisCalcolosi-kidNCT07874087
Epidemiology and Risk Factors of Nephrolithiasis and Nephrocalcinosis With Pediatric Onset
An observational study of Nephrocalcinosis, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
The aim of the study is to build a database of pediatric patients affected by nephrolithiasis or nephrocalcinosis in order to investigate their clinical and epidemiological characteristics. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Nephrocalcinosis
- How many people
- 800 participants
- Where
- 1 siteItaly
- Study dates
- 20 Nov 2021to Dec 2027
- 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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The project involves the collection of epidemiological data from all patients with nephrolithiasis and nephrocalcinosis followed since 2006 at the centers participating in the study
Who may be able to join
- Diagnosis of nephrolithiasis and nephrocalcinosis (confirmed by imaging evaluation or stone passage)
- Metabolic evaluation performed through a comprehensive diagnostic pathway previously agreed upon by the participating centers
- Age < 18 years at diagnosis
- Diagnostic pathway performed by a center participating in the project
Who cannot join
- Age > 18 years at diagnosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Milano, 20122
About this study
The aim of the study is to build a database of pediatric patients affected by nephrolithiasis or nephrocalcinosis in order to investigate their clinical and epidemiological characteristics.
Read the detailed description
The aim of the study is to build a database of pediatric patients affected by nephrolithiasis or nephrocalcinosis in order to investigate their clinical and epidemiological characteristics.
Specifically, the study aims to evaluate, as a primary objective, the prevalence of forms caused by metabolic conditions and/or tubular diseases.
As secondary objectives, it aims to assess:
- Whether the clinical presentation is influenced by the patient's age
- Whether different environmental conditions affect stone composition
- The adherence to dietary and therapeutic recommendations"
- Conditions
- Nephrocalcinosis
- Keywords
- nephrocalcinosis in children
- Medical subject headings
- Nephrocalcinosis
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the prevalence of forms due to known metabolic conditions and/or tubular diseases in a pediatric population affected by nephrolithiasis and nephrocalcinosis
The primary endpoint is the prevalence of forms due to known metabolic conditions and/or tubular diseases in a pediatric population affected by nephrolithiasis and nephrocalcinosis
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start20 Nov 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrocalcinosisStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Montini, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874087
- Sponsor's protocol ID
- 10.11.2021_0045946_U
- Acronym
- Calcolosi-kid
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Risk Factors of Nephrolithiasis and Nephrocalcinosis With Pediatric Onset
- ClinicalTrials.gov ID
- NCT07874087
- Acronym / sponsor ID
- Calcolosi-kid / 10.11.2021_0045946_U
- Conditions
- Nephrocalcinosis
- Keywords
- nephrocalcinosis in children
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 20 Nov 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 Oct 2026 (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.
The aim of the study is to build a database of pediatric patients affected by nephrolithiasis or nephrocalcinosis in order to investigate their clinical and epidemiological characteristics.
Detailed description
The aim of the study is to build a database of pediatric patients affected by nephrolithiasis or nephrocalcinosis in order to investigate their clinical and epidemiological characteristics.
Specifically, the study aims to evaluate, as a primary objective, the prevalence of forms caused by metabolic conditions and/or tubular diseases.
As secondary objectives, it aims to assess:
- Whether the clinical presentation is influenced by the patient's age
- Whether different environmental conditions affect stone composition
- The adherence to dietary and therapeutic recommendations"
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The project involves the collection of epidemiological data from all patients with nephrolithiasis and nephrocalcinosis followed since 2006 at the centers participating in the study
Key inclusion criteria (4 listed)
- Diagnosis of nephrolithiasis and nephrocalcinosis (confirmed by imaging evaluation or stone passage)
- Metabolic evaluation performed through a comprehensive diagnostic pathway previously agreed upon by the participating centers
- Age < 18 years at diagnosis
- Diagnostic pathway performed by a center participating in the project
Key exclusion criteria (1 listed)
- Age > 18 years at diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary endpoint is the prevalence of forms due to known metabolic conditions and/or tubular diseases in a pediatric population affected by nephrolithiasis and nephrocalcinosis
Time frame: 6 years
The primary endpoint is the prevalence of forms due to known metabolic conditions and/or tubular diseases in a pediatric population affected by nephrolithiasis and nephrocalcinosis
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 14 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nephrocalcinosis, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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 4 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is the prevalence of forms due to known metabolic conditions and/or tubular diseases in a pediatric population affected by nephrolithiasis and nephrocalcinosis (time frame: 6 years). 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 14 Oct 2026.