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

13. maj 2026 opdateret af: Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji

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.

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

6000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Polen
    • Warszawa
      • Warsaw, Warszawa, Polen, 02-507
        • Rekruttering
        • National Medical Institute of the Ministry of the Interior and Administration, Clinic of Gastroenterology and Internal Diseases
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Diagnostisk 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.
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.
Diagnostisk 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Prevalence of renal dysfunction in patients with inflammatory bowel disease compared with the general population.
Tidsramme: Baseline and up to 6 months of follow-up.
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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Prevalence of albuminuria assessed by urine albumin-to-creatinine ratio (ACR)
Tidsramme: Baseline and up to 6 months of follow-up.
Albuminuria will be evaluated using the urine albumin-to-creatinine ratio (ACR) measured in spot urine samples. Abnormal ACR values will be used to identify early renal dysfunction in participants.
Baseline and up to 6 months of follow-up.
Prevalence of abnormal renal biochemical parameters
Tidsramme: Baseline and up to 6 months of follow-up.
Assessment of abnormal renal laboratory parameters including serum creatinine and urea levels in participants with and without Inflammatory Bowel Disease.
Baseline and up to 6 months of follow-up.
Association between renal dysfunction and inflammatory bowel disease activity
Tidsramme: Baseline and up to 6 months of follow-up.
Evaluation of the relationship between renal dysfunction and disease activity in patients with IBD assessed using the Total Mayo Score for Ulcerative Colitis and the Crohn's Disease Activity Index (CDAI) for Crohn Disease.
Baseline and up to 6 months of follow-up.
Association between renal dysfunction and medications used in inflammatory bowel disease
Tidsramme: Baseline and up to 6 months of follow-up.
Assessment of the association between renal abnormalities and medications used for IBD treatment, including 5-aminosalicylates, immunosuppressants, and biologic therapies.
Baseline and up to 6 months of follow-up.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji

Samarbejdspartnere

Jagiellonian University
Medical University of Lodz
Medical University of Silesia
Poznan University of Medical Sciences
Nicolaus Copernicus university Collegium Medicum, Bydgoszcz, Poland

Efterforskere

  • Studieleder: Grażyna Rydzewska, Professor, National Medical Institute of the Ministry of the Interior and Administration, Clinic of Gastroenterology and Internal Diseases.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. november 2025

Primær færdiggørelse (Anslået)

30. november 2026

Studieafslutning (Anslået)

30. december 2026

Datoer for studieregistrering

Først indsendt

24. marts 2026

Først indsendt, der opfyldte QC-kriterier

13. maj 2026

Først opslået (Faktiske)

18. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 43/BW/2025 (Registry Identifier: CWBK PIM MSWiA register)

Plan for individuelle deltagerdata (IPD)

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UBESLUTET

IPD-planbeskrivelse

De-identified individual participant data may be available upon reasonable request from the principal investigator.

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