Renal Dysfunction in Patients With Inflammatory Bowel Disease and the General Population (NEPHRO-… (NCT07593352) | Clinical Trial Compass
RecruitingNot Applicable
Renal Dysfunction in Patients With Inflammatory Bowel Disease and the General Population (NEPHRO-IBD)
Poland6,000 participantsStarted 2025-11-20
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prevalence of renal dysfunction in patients with inflammatory bowel disease compared with the general population.
Timeframe: Baseline and up to 6 months of follow-up.
Trial details
NCT IDNCT07593352
SponsorPaństwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji