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Clinical Trials in Italy / NCT07670988
Recruiting Observational

Epidemiological Evaluation Of Chronic Kidney Disease In Pediatric Patients With Inflammatory Bowel Disease

NCT07670988 · tracked via the Priya Life Science Italy tracker
Sponsor
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Phase
Observational
Started
2026-09-01
Last updated
2026-06-26

Condition(s) studied

Inflammatory Bowel Diseases (IBD)

Investigational drug(s) / intervention(s)

Clinical and Laboratory Data Collection

Clinical and Laboratory Data Collection: 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 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.

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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
17 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

  • Prevalence of Chronic Kidney Disease in Pediatric IBD Patients — 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.

Trial sites (1)

FacilityCityRegionStatus
Pediatric Unit Alessandria Piedmont Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07670988 on ClinicalTrials.gov ↗ ← All trials in Italy