Hidden kidney risk in IBD: 6,000-Person study launches
NCT ID NCT07593352
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study will compare kidney function in 3,000 adults with Crohn's disease or ulcerative colitis to 3,000 adults without these conditions. Participants will provide blood and urine samples and have a kidney ultrasound. The goal is to learn how common kidney problems are in IBD and what factors might increase the risk.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 6,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Medical Institute of the Ministry of the Interior and Administration, Clinic of Gastroenterology and Internal Diseases
RECRUITINGWarsaw, Warszawa, 02-507, Poland
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