Inflammatory Bowel Diseases (IBD)KIBDNCT07670988
Epidemiological Evaluation Of Chronic Kidney Disease In Pediatric Patients With Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Diseases (IBD), run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
Trial summary
This multicenter observational cross-sectional study aims to evaluate the prevalence of chronic kidney disease (CKD) in pediatric patients with inflammatory bowel disease (IBD) and to compare it with a control group without IBD. Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases (IBD)
- What is being tested?
- Clinical and Laboratory Data Collection
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2026to Jan 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 2 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Pediatric patients aged 2 to 17 years recruited from participating centers, including patients with inflammatory bowel disease and a matched control group without IBD.
Who may be able to join
- Pediatric patients aged between 2 and 17 years
- For the case group: confirmed diagnosis of inflammatory bowel disease according to Porto criteria
- For the control group: absence of current or previous diagnosis of inflammatory bowel disease
- Availability of clinical and laboratory data required for study evaluation
- Written informed consent from parent or legal guardian, and assent from the minor when applicable
Who cannot join
- History of pre-existing renal disease (congenital or acquired before IBD diagnosis)
- Presence of conditions that may affect renal function (e.g., diabetes mellitus, hypertension, chronic use of nephrotoxic drugs)
- Lack of informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Clinical Trial Center (CTC) Clinical Trial Center (CTC) contact
Italy1 site, 1 recruiting
- Recruiting
Pediatric Unit
Alessandria, Piedmont, 15121
Clinical Trial Center (CTC), 0131206893, clinicaltrialcenter@ospedale.al.it
About this study
Official title: A Multicenter, Cross-sectional Observational Study for the Epidemiological Evaluation of Chronic Kidney Disease in Pediatric Patients With Inflammatory Bowel Disease, and Its Relationship With Disease Activity and Medical Therapy.
This multicenter observational cross-sectional study aims to evaluate the prevalence of chronic kidney disease (CKD) in pediatric patients with inflammatory bowel disease (IBD) and to compare it with a control group without IBD.
Inflammatory bowel diseases, including Crohn's disease and ulcerative colitis, are chronic conditions that can also affect organs outside the intestine. Among these, kidney involvement has been reported, but data in pediatric populations are limited.
Read more
The study will collect clinical, laboratory, and demographic data from pediatric patients with IBD and matched controls without IBD. The main objective is to estimate the prevalence of CKD in children with IBD and compare it with that observed in the control group. Secondary objectives include describing patient characteristics and exploring potential associations between CKD, disease activity, and medical therapies.
The results of this study may improve the understanding of kidney complications in pediatric IBD and support earlier diagnosis and better clinical management.
Read the detailed description
Inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis, are chronic relapsing conditions that frequently begin during childhood or adolescence. In pediatric patients, IBD often presents with more severe disease phenotypes and may be associated with extraintestinal manifestations involving multiple organ systems.
Renal involvement is among the reported extraintestinal manifestations of IBD and includes a wide spectrum of conditions, such as nephrolithiasis, tubulointerstitial nephritis, glomerulonephritis, and chronic kidney disease (CKD). While these complications are relatively well described in adult populations, epidemiological data in pediatric patients remain limited, particularly in the Italian setting.
Understanding the prevalence of CKD and its potential associations with disease activity and medical therapy is essential to improve early detection and long-term outcomes in pediatric patients with IBD.
- Conditions
- Inflammatory Bowel Diseases (IBD)
- Being tested
- Clinical and Laboratory Data Collection
- Keywords
- Pediatric IBD
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and Laboratory Data CollectionOther
Collection of anonymized clinical, demographic, laboratory, and therapeutic data from pediatric patients with inflammatory bowel disease (IBD) and matched controls. Data are collected through review of medical records and routine clinical assessments, including renal function evaluation (eGFR, creatinine, albuminuria), disease activity indices, and treatment history. No experimental intervention or modification of standard clinical practice is performed.
| Study group | Role | What they receive |
|---|---|---|
| IBD Patients | Pediatric patients aged 2 to 17 years with a confirmed diagnosis of inflammatory bowel disease, including Crohn disease, ulcerative colitis, or unclassified IBD. Data are collected from medical records without any intervention. | |
| Control Group | Pediatric patients aged 2 to 17 years without a diagnosis of inflammatory bowel disease, matched by age, sex, and recruiting center. Data are collected from medical records without any intervention. Receives: Other: Clinical and Laboratory Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Chronic Kidney Disease in Pediatric IBD Patients
Prevalence of patient with chronic kidney disease, compared with a matched control group without inflammatory bowel disease. Chronic kidney disease will be defined using estimated glomerular filtration rate (eGFR) calculated with the Schwartz formula and/or presence of albuminuria.
Measured: At study enrollment (cross-sectional assessment)
Secondary outcomes (1)
Association Between Disease Activity and Chronic Kidney Disease
Assessment of the association between disease activity indices (e.g., PUCAI, PCDAI), laboratory parameters, and the presence of chronic kidney disease in pediatric patients with inflammatory bowel disease.
Measured: At study enrollment (cross-sectional assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Diseases (IBD)Studies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670988
- Sponsor's protocol ID
- ASO.Ped.25.06
- Acronym
- KIBD
- Status last verified
- Apr 2026
- First submitted
- 22 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- 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 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Cross-sectional Observational Study for the Epidemiological Evaluation of Chronic Kidney Disease in Pediatric Patients With Inflammatory Bowel Disease, and Its Relationship With Disease Activity and Medical Therapy.
- ClinicalTrials.gov ID
- NCT07670988
- Acronym / sponsor ID
- KIBD / ASO.Ped.25.06
- Conditions
- Inflammatory Bowel Diseases (IBD)
- Keywords
- Pediatric IBD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di AlessandriaUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 26 Jun 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.
This multicenter observational cross-sectional study aims to evaluate the prevalence of chronic kidney disease (CKD) in pediatric patients with inflammatory bowel disease (IBD) and to compare it with a control group without IBD.
Inflammatory bowel diseases, including Crohn's disease and ulcerative colitis, are chronic conditions that can also affect organs outside the intestine. Among these, kidney involvement has been reported, but data in pediatric populations are limited.
The study will collect clinical, laboratory, and demographic data from pediatric patients with IBD and matched controls without IBD. The main objective is to estimate the prevalence of CKD in children with IBD and compare it with that observed in the control group. Secondary objectives include describing patient characteristics and exploring potential associations between CKD, disease activity, and medical therapies.
The results of this study may improve the understanding of kidney complications in pediatric IBD and support earlier diagnosis and better clinical management.
Detailed description
Inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis, are chronic relapsing conditions that frequently begin during childhood or adolescence. In pediatric patients, IBD often presents with more severe disease phenotypes and may be associated with extraintestinal manifestations involving multiple organ systems.
Renal involvement is among the reported extraintestinal manifestations of IBD and includes a wide spectrum of conditions, such as nephrolithiasis, tubulointerstitial nephritis, glomerulonephritis, and chronic kidney disease (CKD). While these complications are relatively well described in adult populations, epidemiological data in pediatric patients remain limited, particularly in the Italian setting.
Understanding the prevalence of CKD and its potential associations with disease activity and medical therapy is essential to improve early detection and long-term outcomes in pediatric patients with IBD.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBD Patients | – | –Pediatric patients aged 2 to 17 years with a confirmed diagnosis of inflammatory bowel disease, including Crohn disease, ulcerative colitis, or unclassified IBD. Data are collected from medical records without any intervention. |
| Control Group | – | Other: Clinical and Laboratory Data CollectionPediatric patients aged 2 to 17 years without a diagnosis of inflammatory bowel disease, matched by age, sex, and recruiting center. Data are collected from medical records without any intervention. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pediatric patients aged 2 to 17 years recruited from participating centers, including patients with inflammatory bowel disease and a matched control group without IBD.
Key inclusion criteria (5 listed)
- Pediatric patients aged between 2 and 17 years
- For the case group: confirmed diagnosis of inflammatory bowel disease according to Porto criteria
- For the control group: absence of current or previous diagnosis of inflammatory bowel disease
- Availability of clinical and laboratory data required for study evaluation
- Written informed consent from parent or legal guardian, and assent from the minor when applicable
Key exclusion criteria (3 listed)
- History of pre-existing renal disease (congenital or acquired before IBD diagnosis)
- Presence of conditions that may affect renal function (e.g., diabetes mellitus, hypertension, chronic use of nephrotoxic drugs)
- Lack of informed consent
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 |
|---|---|---|
| Clinical and Laboratory Data CollectionCollection of anonymized clinical, demographic, laboratory, and therapeutic data from pediatric patients with inflammatory bowel disease (IBD) and matched controls. Data are collected through review of medical records and routine clinical assessments, including renal function evaluation (eGFR, creatinine, albuminuria), disease activity indices, and treatment history. No experimental intervention or modification of standard clinical practice is performed. | Other | Control Group |
Primary outcome
Prevalence of Chronic Kidney Disease in Pediatric IBD Patients
Time frame: At study enrollment (cross-sectional assessment)
Prevalence of patient with chronic kidney disease, compared with a matched control group without inflammatory bowel disease. Chronic kidney disease will be defined using estimated glomerular filtration rate (eGFR) calculated with the Schwartz formula and/or presence of albuminuria.
1 secondary outcome
Association Between Disease Activity and Chronic Kidney Disease
Time frame: At study enrollment (cross-sectional assessment)
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 26 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Clinical Trial Center (CTC) Clinical Trial Center (CTC) contact
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 Inflammatory Bowel Diseases (IBD), run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria 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 5 inclusion and 3 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 26 Jun 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?
Contact Clinical Trial Center (CTC) Clinical Trial Center (CTC) (0131206893, clinicaltrialcenter@ospedale.al.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Chronic Kidney Disease in Pediatric IBD Patients (time frame: At study enrollment (cross-sectional assessment)). 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 26 Jun 2026.