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

13 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

6000

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Polonia
    • Warszawa
      • Warsaw, Warszawa, Polonia, 02-507
        • Reclutamento
        • National Medical Institute of the Ministry of the Interior and Administration, Clinic of Gastroenterology and Internal Diseases
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Metodo di campionamento

Campione di probabilità

Popolazione di studio

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.

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Test diagnostico: 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.
Test diagnostico: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Prevalence of renal dysfunction in patients with inflammatory bowel disease compared with the general population.
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Prevalence of albuminuria assessed by urine albumin-to-creatinine ratio (ACR)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji

Collaboratori

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

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 novembre 2025

Completamento primario (Stimato)

30 novembre 2026

Completamento dello studio (Stimato)

30 dicembre 2026

Date di iscrizione allo studio

Primo inviato

24 marzo 2026

Primo inviato che soddisfa i criteri di controllo qualità

13 maggio 2026

Primo Inserito (Effettivo)

18 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 43/BW/2025 (Identificatore di registro: CWBK PIM MSWiA register)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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