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

NCT07670988 | Recruiting

• 1 other identifier: ASO.Ped.25.06
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Bowel Diseases (IBD)

Keywords

Pediatric IBD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Association Between Disease Activity and Chronic Kidney Disease

  At study enrollment (cross-sectional assessment)

Study Arms (2)

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

Interventions

Clinical and Laboratory Data Collection OTHER

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.

Control Group

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Pediatric Unit

Alessandria, Piedmont, 15121, Italy

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Clinical Trial Center (CTC) Clinical Trial Center (CTC)

CONTACT

0131206893; clinicaltrialcenter@ospedale.al.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 26, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)