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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-17
SponsorAzienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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 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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Clinical and Laboratory Data Collection

    Other intervention

    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.

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: IBD Patients0 interventions
Group B: Control Group1 intervention

Trial outcomes

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.

Time frame
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.

Time frame
At study enrollment (cross-sectional assessment)

Other outcomes

Sponsors and contacts

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