💬In plain words
What the trial is, and whether it could suit you
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 indi
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📋 Eligibility rules (as published)
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)
💊
What it tests
- 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.
National Medical Institute of the Ministry of the Interior and Administration, Clinic of Gastroenterology and Internal Diseases
Warsaw, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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