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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.

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Poland
National Medical Institute of the Ministry of the Interior and Administration, Clinic of Gastroenterology and Internal Diseases
RECRUITING
Warsaw
Contact Information
Primary
Krzysztof Jaroń, MD, MPharm
krzysztof.jaron@pimmswia.gov.pl
+48 477 22 12 40
Backup
Konrad Lewandowski, Associate/Assistant Professor
konrad.lewandowski@pimmswia.gov.pl
+ 48 477 22 12 40
Time Frame
Start Date: 2025-11-20
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 6000
Treatments
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.
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.
Sponsors
Collaborators: Medical University of Lodz, Jagiellonian University, Medical University of Silesia, Poznan University of Medical Sciences, Nicolaus Copernicus university Collegium Medicum, Bydgoszcz, Poland
Leads: Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji

This content was sourced from clinicaltrials.gov