NCT07593352 Renal Dysfunction in Patients With Inflammatory Bowel Disease and the General Population (NEPHRO-IBD)
| NCT ID | NCT07593352 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji |
| Condition | IBD and Renal Involement |
| Study Type | OBSERVATIONAL |
| Enrollment | 6,000 participants |
| Start Date | 2025-11-20 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 6,000 participants in total. It began in 2025-11-20 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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)
Contact & Investigator
Grażyna Rydzewska, Professor
STUDY DIRECTOR
National Medical Institute of the Ministry of the Interior and Administration, Clinic of Gastroenterology and Internal Diseases.
Frequently Asked Questions
Who can join the NCT07593352 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying IBD and Renal Involement. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07593352 currently recruiting?
Yes, NCT07593352 is actively recruiting participants. Contact the research team at krzysztof.jaron@pimmswia.gov.pl for enrollment information.
Where is the NCT07593352 trial being conducted?
This trial is being conducted at Warsaw, Poland.
Who is sponsoring the NCT07593352 clinical trial?
NCT07593352 is sponsored by Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji. The principal investigator is Grażyna Rydzewska, Professor at National Medical Institute of the Ministry of the Interior and Administration, Clinic of Gastroenterology and Internal Diseases.. The trial plans to enroll 6,000 participants.