Renal Dysfunction in Patients With Inflammatory Bowel Disease and the General Population (NEPHRO-IBD)

NCT07593352 | Recruiting

• 1 other identifier: 43/BW/2025
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

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.

Conditions

IBD and Renal Involement; Chronic Kidney Disease; Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis)

Keywords

IBD; Crohn's Disease; Ulcerative Colitis; Renal Dysfunction; Chronic Kidney Disease; Extraintestinal Manifestations; Renal Complications in IBD; Albumin-to-Creatinine Ratio

Outcome Measures

Primary Outcomes (1)

• Prevalence of renal dysfunction in patients with inflammatory bowel disease compared with the general population.

  Evaluation of the association between the occurrence of kidney disease and IBD activity (including measurement of fecal calprotectin levels), as well as medications used and comorbidities.

  Baseline and up to 6 months of follow-up.

Secondary Outcomes (4)

• Prevalence of albuminuria assessed by urine albumin-to-creatinine ratio (ACR)

  Baseline and up to 6 months of follow-up.

• Prevalence of abnormal renal biochemical parameters

  Baseline and up to 6 months of follow-up.

• Association between renal dysfunction and inflammatory bowel disease activity

  Baseline and up to 6 months of follow-up.

• Association between renal dysfunction and medications used in inflammatory bowel disease

  Baseline and up to 6 months of follow-up.

Study Arms (2)

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.

Diagnostic Test: 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.

Diagnostic Test: 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.

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.

Control group - patients without IBD; Study group: IBD patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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:
• Gold salts

Sponsors & Collaborators

• Poznan University of Medical Sciences: collaborator
• Nicolaus Copernicus university Collegium Medicum, Bydgoszcz, Poland: collaborator
• Medical University of Lodz: collaborator
• Jagiellonian University: collaborator
• Medical University of Silesia: collaborator
• Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji: lead

Study Sites (1)

National Medical Institute of the Ministry of the Interior and Administration, Clinic of Gastroenterology and Internal Diseases

Warsaw, Warszawa, 02-507, Poland

RECRUITING

Related Publications (4)

• Wang H, Shi L, Qin J, Yousefi S, Li Y, Wang RK. Multimodal optical imaging can reveal changes in microcirculation and tissue oxygenation during skin wound healing. Lasers Surg Med. 2014 Aug;46(6):470-8. doi: 10.1002/lsm.22254. Epub 2014 May 1.

  PMID: 24788236 BACKGROUND

• Lapane KL, Jakiche AF, Sugano D, Weng CS, Carey WD. Hepatitis C infection risk analysis: who should be screened? Comparison of multiple screening strategies based on the National Hepatitis Surveillance Program. Am J Gastroenterol. 1998 Apr;93(4):591-6. doi: 10.1111/j.1572-0241.1998.170_b.x.

  PMID: 9576453 BACKGROUND

• Liu M, Zhang Y, Ye Z, Yang S, Zhou C, He P, Zhang Y, Hou FF, Qin X. Inflammatory Bowel Disease With Chronic Kidney Disease and Acute Kidney Injury. Am J Prev Med. 2023 Dec;65(6):1103-1112. doi: 10.1016/j.amepre.2023.08.008. Epub 2023 Aug 10.

  PMID: 37572855 BACKGROUND

• Gordon H, Burisch J, Ellul P, Karmiris K, Katsanos K, Allocca M, Bamias G, Barreiro-de Acosta M, Braithwaite T, Greuter T, Harwood C, Juillerat P, Lobaton T, Muller-Ladner U, Noor N, Pellino G, Savarino E, Schramm C, Soriano A, Michael Stein J, Uzzan M, van Rheenen PF, Vavricka SR, Vecchi M, Zuily S, Kucharzik T. ECCO Guidelines on Extraintestinal Manifestations in Inflammatory Bowel Disease. J Crohns Colitis. 2024 Jan 27;18(1):1-37. doi: 10.1093/ecco-jcc/jjad108. No abstract available.

  PMID: 37351850 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Colitis, Ulcerative; Crohn Disease; Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Grażyna Rydzewska, Professor

  National Medical Institute of the Ministry of the Interior and Administration, Clinic of Gastroenterology and Internal Diseases.

  STUDY DIRECTOR

Central Study Contacts

Krzysztof Jaroń, MD, MPharm

CONTACT

+48 477 22 12 40; krzysztof.jaron@pimmswia.gov.pl

Konrad Lewandowski, Associate/Assistant Professor

CONTACT

+ 48 477 22 12 40; konrad.lewandowski@pimmswia.gov.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: May 18, 2026
• Study Start: November 20, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

PL (1)