Crohn'sUCRecruiting
Renal Dysfunction in Patients With Inflammatory Bowel Disease and the General Population (NEPHRO-IBD)
Observational · No treatment assigned · 1 site · Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: IBD and Renal Involement, Chronic Kidney Disease and Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis). This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 to 80
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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
Plus 1 more requirement(s). There are also 27 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 6000 participants are expected to take part.
- Start date: 2025-11-20.
- Main results expected around 2026-11-30 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Poland.
Main thing being measured
- Prevalence of renal dysfunction in patients with inflammatory bowel disease compared with the general population. (Baseline and up to 6 months of follow-up.)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | IBD and Renal Involement; Chronic Kidney Disease; Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis) |
| Lead sponsor | Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji |
| Collaborators | Poznan University of Medical Sciences; Nicolaus Copernicus university Collegium Medicum, Bydgoszcz, Poland; Medical University of Lodz; Jagiellonian University; Medical University of Silesia |
| Enrollment | 6000 (estimated) |
| Start date | 2025-11-20 |
| Primary completion (est.) | 2026-11-30 |
| First posted | 2026-05-18 |
| Last updated | 2026-05-18 |
| 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. |
| ClinicalTrials.gov ID | NCT07593352 |
Interventions
- 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. (Diagnostic Test)
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.
Full eligibility criteria (from the record)
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)
| Site | City | Country | Site status |
|---|---|---|---|
| National Medical Institute of the Ministry of the Interior and Administration, Clinic of Gastroenterology and Internal Diseases | Warsaw, Warszawa | Poland | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.