Kidney Problems in People With Crohn's Disease or Ulcerative Colitis
Compares how often kidney problems occur in adults with inflammatory bowel disease versus others.
Key facts
- Who runs it
- Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji
- Where
- Warsaw, PolandSee the site
- Trial code
- Registry title
- Renal Dysfunction in Patients With Inflammatory Bowel Disease and the General Population (NEPHRO-IBD)
- Status
- Recruiting
- People taking part
- 6,000 people, planned
- Started
- 20 Nov 2025
- Expected to end
- 30 Dec 2026
- Type of study
- Observational, 2 groups
- Treatments tested
- 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.
- Record updated
- 18 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with inflammatory bowel disease (Crohn's disease or ulcerative colitis), and also adults without it as a comparison group. It checks how common kidney problems are.
- Age
- Over 18 years; the exclusion list also says under 18 or over 80 cannot join (registry range 18 to 80 years).
- Sex
- All sexes can join.
- Disease stage
- Inflammatory bowel disease confirmed by the overall clinical picture and an endoscopy, or no inflammatory bowel disease (comparison group).
- Earlier treatment
- People cannot have used kidney-harming medicines (nephrotoxic drugs) within a month before and during the study. They also cannot have started angiotensin inhibitors, sartans or flozins less than 3 months ago.
Main reasons for not taking part
- Diabetes
- Pregnancy
- Signs of a urinary tract infection
- Other serious illnesses or earlier surgery that could change kidney test results
- Dehydration
The registry criteria, word for word
Show all 30 criteriaShow less
Who can take part
- 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
Who cannot take part
- in women, menstruation (urinalysis can be performed 3 days before the onset and 3 days after the end of menstruation)
- 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
- 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
- Antituberculosis drugs (rifampicin, ethambutol, isoniazid)
- Antiviral drugs (acyclovir)
- Oncology drugs (cisplatin)
- diabetes
- dysuric symptoms suggestive of urinary tract infections
- 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
- age under 18 or over 80
- refusal to participate in all procedures performed in the study
- pregnancy
- 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
- Gold salts
- Penicillamine
- Interferon alpha
- Pamidronate
- Biseptol
- Anticonvulsants (carbamazepine, diazepam, phenobarbital)
- Cyclosporine A, tacrolimus
- Chinese herbs
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in Poland
- National Medical Institute of the Ministry of the Interior and Administration, Clinic of Gastroenterology and Internal DiseasesWarsaw, PolandContact: Grażyna Rydzewska, ProfessorTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Study group: IBD patients
Routine blood and urine tests performed every 3 and 6 months: peripheral blood count, CRP, glucose, total cholesterol, LDL, HDL, TGL, sodium, potassium, magnesium, phosphorus, uric acid, vitamin D3, albumin, urea, creatinine, calprotectin, and urinalysis with creatinine/albumin ratio (ACR) assessment. Assessment of the urinary system in abdominal ultrasound.
Treatment: 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.
- Control group - patients without IBD
Routine blood and urine tests performed every 3 and 6 months: peripheral blood count, CRP, glucose, total cholesterol, LDL, HDL, TGL, sodium, potassium, magnesium, phosphorus, uric acid, vitamin D3, albumin, urea, creatinine, calprotectin, and urinalysis with creatinine/albumin ratio (ACR) assessment. Assessment of the urinary system in abdominal ultrasound.
Treatment: 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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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.
- Plain-language title
- Kidney Problems in People With Crohn's Disease or Ulcerative ColitisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Fit questions
- Built from NCT07593352, who can take part
- Record updated
- 18 May 2026