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.
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
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
The study population will consist of adult participants recruited at multiple gastroenterology centers in Poland. The study will include approximately 6,000 individuals, including 3,000 patients with confirmed Inflammatory Bowel Disease (Crohn's disease or ulcerative colitis) and 3,000 individuals without IBD serving as a control group from the general population. Patients with IBD will be identified based on clinical evaluation and endoscopic confirmation of disease. Control participants will include adults without a diagnosis of inflammatory bowel disease who meet the study eligibility criteria. All participants will undergo clinical assessment, laboratory testing including blood tests and urinalysis with measurement of the albumin-to-creatinine ratio (ACR), and abdominal ultrasound evaluation of the kidneys and urinary tract. In patients with IBD, disease activity will additionally be assessed using validated clinical indices.
Cohort
Prospective
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.
Diagnostic testNo experimental intervention is performed. Participants undergo routine clinical evaluation, laboratory testing, urinalysis including albumin-to-creatinine ratio (ACR), and abdominal ultrasound as part of observational data collection.
Prevalence of renal dysfunction in patients with inflammatory bowel disease compared with the general population.
Evaluation of the association between the occurrence of kidney disease and IBD activity (including measurement of fecal calprotectin levels), as well as medications used and comorbidities.
Prevalence of albuminuria assessed by urine albumin-to-creatinine ratio (ACR)
Albuminuria will be evaluated using the urine albumin-to-creatinine ratio (ACR) measured in spot urine samples. Abnormal ACR values will be used to identify early renal dysfunction in participants.
Prevalence of abnormal renal biochemical parameters
Assessment of abnormal renal laboratory parameters including serum creatinine and urea levels in participants with and without Inflammatory Bowel Disease.
Association between renal dysfunction and inflammatory bowel disease activity
Evaluation of the relationship between renal dysfunction and disease activity in patients with IBD assessed using the Total Mayo Score for Ulcerative Colitis and the Crohn's Disease Activity Index (CDAI) for Crohn Disease.
Association between renal dysfunction and medications used in inflammatory bowel disease
Assessment of the association between renal abnormalities and medications used for IBD treatment, including 5-aminosalicylates, immunosuppressants, and biologic therapies.
Click on the lead sponsor to view all of their trials.
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
