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NCT Number: NCT06717516

Renal Involvement in Adult Patients With Inflammatory Bowel Disease and Its Relation to Duration and Disease Activity

To Assess the pattern of renal injury in patients with inflammatory bowel disease and its relation to the duration and disease activity by Identification and characterization of early renal manifestations (e.g., proteinuria, hematuria, electrolyte imbalances) in IBD patients. and know Correlation between kidney involvement and IBD severity, including flare-ups and complications.

and know Impact of early renal manifestations on long-term renal outcomes, such as progression to CKD or development of AKI.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

Inflammatory bowel disease (IBD), comprising ulcerative colitis (UC) and Crohn's disease (CD), is a chronic immunemediated disorder of the gastro-intestinal tract characterized by recurrent inflammation and epithelial injury of the intestine. Extraintestinal manifestations are seen in 6% to 47% of patients diagnosed with IBD. Renal and urinary tract involvement occurs in 4% to 23% of patients with IBD, with renal calculi being the most common form of renal involvement. IBD is associated with a range of renal manifestations, including nephrolithiasis, glomerulonephritis, tubulointerstitial nephritis, and secondary amyloidosis, which can lead to acute or chronic renal insufficiency. Several potential mechanisms might contribute to the higher risk of incident CKD and AKI in patients with IBD. First, in the context of IBD, acute or chronic loss of circulating volume (salt and water depletion) due to persistent inflammation of the intestine and repeated intestinal resection could lead to electrolyte abnormalities followed by acute and chronic loss of kidney function, which may not be always reversible. Second, dysbiosis in patients with IBD is associated with increased production of microbiota-derived uremic toxins and microinflammation, both of which promote the progression of renal diseases. Third, IBD-related alterations in the innate and adaptive immune systems may lead to elevated proinflammatory cytokines, which are particularly implicated in the progression of renal disease. Understanding these associations is crucial for management and monitoring of IBD patients, particularly for those who may develop renal complications, so mitigating impact on kidney function and overall health.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 years or older
  • Confirmed diagnosis of IBD either crohns disease or ulcerative colities based on clinical ,endoscopic ,histological and radiological findings . - Patients in any stage of IBD, including remission, active disease, and flare-ups. - Willingness to participate and provide informed consent. - Renal Assessment for participants.

Exclusion criteria

  • Pre-existing chronic kidney disease (CKD) at any stage. - Known primary kidney diseases unrelated to IBD. - Current use of nephrotoxic medications not related to IBD treatment. - Pregnancy or breastfeeding. - Patients who are unable to comply with study protocols or follow-up assessment - Presence of other significant comorbidities that impact renal function or overall health

Treatment and study plan

Primary outcomes

  1. Identification of renal manifestations in IBD patients and Correlation between kidney involvement and IBD severity, including flare-ups and complications and its Impact on long-term renal outcomes, such as progression to CKD or development of AKI

    Time frame: scheduled follow-ups at 3,6,12 months

    Identification and characterization of renal manifestations (e.g., proteinuria, hematuria, electrolyte imbalances) in IBD patients and Correlation between kidney involvement and IBD severity, including flare-ups and complications and Impact of early renal manifestations on long-term renal outcomes, such as progression to CKD or development of AKI

Study contacts

Contact information is provided by the study sponsor or research team.

Esraa Abdel-Aal Khalifa Abdel-Aal

CONTACT

[email protected]

+201021250942

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Renal Involvement in Adult Patients With Inflammatory Bowel Disease and Its Relation to Duration and Disease Activity .

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 5, 2024
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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