Renal Dysfunction in Patients With Inflammatory Bowel Disease and the General Population (NEPHRO-IBD) (NEPHRO-IBD)
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.
Visão geral do estudo
Status
Condições
Descrição detalhada
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 de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Krzysztof Jaroń, MD, MPharm
- Número de telefone: +48 477 22 12 40
- E-mail: krzysztof.jaron@pimmswia.gov.pl
Estude backup de contato
- Nome: Konrad Lewandowski, Associate/Assistant Professor
- Número de telefone: + 48 477 22 12 40
- E-mail: konrad.lewandowski@pimmswia.gov.pl
Locais de estudo
-
-
Warszawa
-
Warsaw, Warszawa, Polônia, 02-507
- Recrutamento
- National Medical Institute of the Ministry of the Interior and Administration, Clinic of Gastroenterology and Internal Diseases
-
Contato:
- Grażyna Rydzewska, Professor
- Número de telefone: +48 477 22 12 40
- E-mail: grażyna.rydzewska@pimmswia.gov.pl
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
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.
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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. |
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. |
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Prevalence of renal dysfunction in patients with inflammatory bowel disease compared with the general population.
Prazo: 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.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Prevalence of albuminuria assessed by urine albumin-to-creatinine ratio (ACR)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.
|
Colaboradores e Investigadores
Colaboradores
Investigadores
- Diretor de estudo: Grażyna Rydzewska, Professor, National Medical Institute of the Ministry of the Interior and Administration, Clinic of Gastroenterology and Internal Diseases.
Publicações e links úteis
Publicações Gerais
- 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.
- 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.
- 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.
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Processos Patológicos
- Doenças Urogenitais Masculinas
- Doenças renais
- Doenças Urológicas
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Doença crônica
- Atributos da doença
- Doenças Intestinais
- Doenças do aparelho digestivo
- Doenças Gastrointestinais
- Doenças do cólon
- Gastroenterite
- Doenças Inflamatórias Intestinais
- Colite
- Condições Patológicas, Sinais e Sintomas
- Colite ulcerativa
- Doença de Crohn
- Insuficiência renal
- Insuficiência Renal Crônica
Outros números de identificação do estudo
- 43/BW/2025 (Identificador de registro: CWBK PIM MSWiA register)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .