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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Clinical Trial Center (CTC) Clinical Trial Center (CTC)
- Telefoonnummer: 0131206893
- E-mail: clinicaltrialcenter@ospedale.al.it
Studie Locaties
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Piedmont
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Alessandria, Piedmont, Italië, 15121
- Werving
- Pediatric Unit
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Contact:
- Clinical Trial Center (CTC)
- Telefoonnummer: 0131206893
- E-mail: clinicaltrialcenter@ospedale.al.it
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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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.
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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.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Prevalence of Chronic Kidney Disease in Pediatric IBD Patients
Tijdsspanne: At study enrollment (cross-sectional assessment)
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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.
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At study enrollment (cross-sectional assessment)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Association Between Disease Activity and Chronic Kidney Disease
Tijdsspanne: At study enrollment (cross-sectional assessment)
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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.
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At study enrollment (cross-sectional assessment)
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ASO.Ped.25.06
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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