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NCT07593352

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

Sponsor: Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji

View on ClinicalTrials.gov

Summary

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.

Official title: A Multicenter, Prospective, Observational Study Comparing the Prevalence of Renal Dysfunction in Adult Patient With Inflammatory Bowel Disease Between General Population: The NEPHRO-IBD Study.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

6000

Start Date

2025-11-20

Completion Date

2026-12-30

Last Updated

2026-05-18

Healthy Volunteers

Yes

Conditions

IBD and Renal Involement Chronic Kidney Disease Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis)

Interventions

DIAGNOSTIC_TEST

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.

No 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.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * age under 18 or over 80 * pregnancy * other serious comorbidities whose presence or exacerbation may cause abnormalities in laboratory tests suggesting kidney disease * previous surgery whose presence may cause abnormalities in laboratory tests suggesting kidney disease * extreme physical exertion within 7 days before the test (marathons, half-marathons, triathlons) and intense physical exertion - strength training - within 1 day before the test. \[moderate physical exertion such as walking, swimming, or cycling is not a contraindication\]. • Excessive alcohol consumption 14 days before the study * Inability to perform necessary tests: e.g., inability to perform an imaging test * Unavailability of data: if the study is based on registry data, exclusion of individuals for whom there is incomplete data * Dehydration * Use of nephrotoxic medications\* within a month before and during the study * Use of angiotensin inhibitors, sartans, or flozins that were introduced into treatment within \<3 months \*Nephrotoxic drugs: * Nonsteroidal anti-inflammatory drugs (NSAIDs) - occasional use is not contraindicated, but use for ≥ 10 days is an exclusion criterion * Gold salts * Penicillamine * Interferon alpha * Antituberculosis drugs (rifampicin, ethambutol, isoniazid) * Pamidronate * Biseptol * Antiviral drugs (acyclovir) * Anticonvulsants (carbamazepine, diazepam, phenobarbital) * Cyclosporine A, tacrolimus * Chinese herbs * Oncology drugs (cisplatin)

Locations (1)

National Medical Institute of the Ministry of the Interior and Administration, Clinic of Gastroenterology and Internal Diseases

Warsaw, Warszawa, Poland