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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Krzysztof Jaroń, MD, MPharm
- Numéro de téléphone: +48 477 22 12 40
- E-mail: krzysztof.jaron@pimmswia.gov.pl
Sauvegarde des contacts de l'étude
- Nom: Konrad Lewandowski, Associate/Assistant Professor
- Numéro de téléphone: + 48 477 22 12 40
- E-mail: konrad.lewandowski@pimmswia.gov.pl
Lieux d'étude
-
-
Warszawa
-
Warsaw, Warszawa, Pologne, 02-507
- Recrutement
- National Medical Institute of the Ministry of the Interior and Administration, Clinic of Gastroenterology and Internal Diseases
-
Contact:
- Grażyna Rydzewska, Professor
- Numéro de téléphone: +48 477 22 12 40
- E-mail: grażyna.rydzewska@pimmswia.gov.pl
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
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.
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Prevalence of renal dysfunction in patients with inflammatory bowel disease compared with the general population.
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Prevalence of albuminuria assessed by urine albumin-to-creatinine ratio (ACR)
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
|
Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Directeur d'études: Grażyna Rydzewska, Professor, National Medical Institute of the Ministry of the Interior and Administration, Clinic of Gastroenterology and Internal Diseases.
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Processus pathologiques
- Maladies urogénitales masculines
- Maladies rénales
- Maladies urologiques
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Maladie chronique
- Attributs de la maladie
- Maladies intestinales
- Maladies du système digestif
- Maladies gastro-intestinales
- Maladies du côlon
- Gastro-entérite
- Maladies intestinales inflammatoires
- Colite
- Conditions pathologiques, signes et symptômes
- Colite ulcéreuse
- Maladie de Crohn
- Insuffisance rénale
- Insuffisance rénale chronique
Autres numéros d'identification d'étude
- 43/BW/2025 (Identificateur de registre: CWBK PIM MSWiA register)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .