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

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.

Overview

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.

Detailed description

Inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis, are chronic inflammatory disorders of the gastrointestinal tract that are frequently associated with extraintestinal manifestations. These manifestations may involve multiple organ systems, including the musculoskeletal, dermatologic, hepatobiliary, ocular, and renal systems. While several extraintestinal manifestations of IBD have been well described, renal complications remain relatively underrecognized and insufficiently investigated.

Renal manifestations associated with IBD may include nephrolithiasis, amyloidosis, tubulointerstitial nephritis, glomerulonephritis, urinary tract fistulas, and urothelial malignancies. In addition to disease-related mechanisms, potential contributing factors include immune dysregulation, genetic susceptibility, environmental factors, and nephrotoxic effects of medications used in the treatment of IBD, such as 5-aminosalicylates or thiopurines.

Previous studies suggest that patients with IBD may have an increased risk of chronic kidney disease (CKD) and acute kidney injury (AKI). However, the true prevalence and determinants of renal dysfunction in patients with IBD remain unclear due to limited prospective data.

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 compared with individuals from the general population. Approximately 6,000 participants will be included, including 3,000 patients with confirmed IBD and 3,000 individuals without IBD serving as a control group.

Participants will undergo clinical assessment and routine laboratory testing at baseline and during follow-up visits performed at intervals of approximately three months. The evaluation will include blood tests, urinalysis with measurement of the urine albumin-to-creatinine ratio (ACR), and imaging assessment of the kidneys and urinary tract using abdominal ultrasound. In patients with IBD, disease activity will be evaluated using validated clinical indices, including the Total Mayo Score for ulcerative colitis and the Crohn's Disease Activity Index (CDAI). Fecal calprotectin levels will also be measured to assess intestinal inflammation.

The study will also investigate potential associations between renal abnormalities and inflammatory bowel disease activity, pharmacological treatment, and comorbid conditions. Early identification of renal dysfunction may facilitate timely nephrological evaluation and implementation of nephroprotective therapy in affected patients.

The results of the NEPHRO-IBD study are expected to improve understanding of renal involvement in inflammatory bowel disease and support the development of strategies for early detection and management of kidney disease in this population.

Interventions

• 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.
  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.

Primary outcome measures

• Prevalence of renal dysfunction in patients with inflammatory bowel disease compared with the general population. [Time frame: Baseline and up to 6 months of follow-up.]

Secondary outcome measures (4)

• Prevalence of albuminuria assessed by urine albumin-to-creatinine ratio (ACR) [Time frame: Baseline and up to 6 months of follow-up.]
• Prevalence of abnormal renal biochemical parameters [Time frame: Baseline and up to 6 months of follow-up.]
• Association between renal dysfunction and inflammatory bowel disease activity [Time frame: Baseline and up to 6 months of follow-up.]
• Association between renal dysfunction and medications used in inflammatory bowel disease [Time frame: Baseline and up to 6 months of follow-up.]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

Poland · 1 center

• National Medical Institute of the Ministry of the Interior and Administration, Clinic of G — Warsaw

Publications

• 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
• 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
• 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
• 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 Cr PMID 37351850

Identifiers

NCT: NCT07593352 · 43/BW/2025 · 43/BW/2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗