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
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