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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases (IBD)
• Intervention / Treatment: Other: Clinical and Laboratory Data Collection

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 Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Clinical Trial Center (CTC) Clinical Trial Center (CTC); Phone Number: 0131206893; Email: clinicaltrialcenter@ospedale.al.it

Study Locations

• Italy
  • Piedmont
    • Alessandria, Piedmont, Italy, 15121
      • Recruiting
      • Pediatric Unit
      • Contact: Clinical Trial Center (CTC); Phone Number: 0131206893; Email: clinicaltrialcenter@ospedale.al.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At study enrollment (cross-sectional assessment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At study enrollment (cross-sectional assessment)

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 26, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Pediatric IBD
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases
• Other Study ID Numbers: ASO.Ped.25.06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No