Renal Dysfunction in Patients With Inflammatory Bowel Disease and the General Population (NEPHRO-IBD)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorPaństwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji

About this trial

The NEPHRO-IBD study is a multicenter prospective observational study designed to evaluate the prevalence of renal dysfunction and renal complications in adult patients with inflammatory bowel disease (IBD) compared with individuals from the general population. Although extraintestinal manifestations are common in IBD, renal involvement remains relatively underrecognized and insufficiently studied.

The study will recruit approximately 6,000 participants, including 3,000 patients with confirmed IBD (Crohn's disease or ulcerative colitis) and 3,000 individuals without IBD serving as a control group. Participants will undergo routine clinical assessment, including laboratory tests, urinalysis with measurement of the albumin-to-creatinine ratio (ACR), and imaging evaluation of the kidneys and urinary tract. Disease activity in patients with IBD will be assessed using validated clinical indices.

The study will also evaluate the relationship between renal dysfunction and disease activity, medications used in IBD treatment, and comorbidities. The results of this study are expected to improve the understanding of renal complications in patients with IBD and support earlier identification and management of kidney disease in this population.

Eligibility criteria

Qualifiers

Age over 18 years

Confirmed IBD based on the overall clinical picture and endoscopic examination, or no IBD (control group without IBD)

Consent to participate in the study

Cognitive abilities sufficient to complete the questionnaires

Disqualifiers

diabetes

dysuric symptoms suggestive of urinary tract infections

in women, menstruation (urinalysis can be performed 3 days before the onset and 3 days after the end of menstruation)

refusal to participate in all procedures performed in the study

Trial design

Treatments tested in this trial

  • Prospective assessment of the prevalence of kidney disease and/or renal complications in patients with IBD/the general population based on routine laboratory test and abdominal ultrasound.

Treatment groups

6,000 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji

Lead sponsor

Poznan University of Medical Sciences

Collaborator

Nicolaus Copernicus university Collegium Medicum, Bydgoszcz, Poland

Collaborator

Medical University of Lodz

Collaborator

Jagiellonian University

Collaborator

Medical University of Silesia

Collaborator