Urinary Biomarkers of Renal Injury in Inflammatory Bowel Disease

Inflammatory Bowel Diseases Clinical Trial

Official title:

Urinary Nephrin and Alpha One Microglobulin as Early Renal Injury Biomarkers in Patients With Inflammatory Bowel Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04282577
• Other study ID #: Kidney in IBD
• Status: Not yet recruiting
• Start date: March 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: February 2020
• Source: Assiut University
• Contact: Noha G Abdelmalik
• Phone: 01005509890
• Email: nohagamalmalik[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study aims to early detection of renal injury in patients diagnosed to have inflammatory bowel disease with normal kidney function test focusing on glomerular filtration barrier injury and tubular injury and it's relation to disease activity so precautions could be taken properly to prevent further renal injury later on .

Description:

Inflammatory bowel disease (IBD) is a chronic and relapsing inflammatory condition of the gastrointestinal tract. Crohn's disease and ulcerative colitis are the two principal types of IBD. The prevalence of IBD has been increasing worldwide . Extraintestinal manifestations of IBD are common, occurring in 6% to 47% of patients involving nearly every organ system .

Renal and urinary system involvement are common in IBD patients with incidence varying from 4% to 23% and is greater in patients with more severe and long-standing disease. Apart from secondary complications, such as nephrolithiasis, hydronephrosis and amyloidosis, other disorders have also been reported. Membranous glomerulonephritis, rapidly progressive glomerulonephritis, mesangiocapillary glomerulonephritis, IgA nephropathy, thin basement membrane disease and kidney granuloma found to be connected with IBD. In addition, non-specific morphological changes in the glomeruli of patients with IBD, like podocyte effacement and mesangial deposition of immunoglobulin and complement have been well documented. Cases of interstitial nephritis reported to be attributed to the nephrotoxic effect of aminosalicylates which used in IBD treatment.

Alpha one microglobulin is a relatively small protein that undergoes glomerular filtration followed by reabsorption and catabolism in the proximal tubules. Increased urinary α1-microglobulin concentration therefore provides an index of proximal tubule dysfunction .

Glomerular filtration barrier related protein changes have not been closely investigated in IBD patients . Nephrin is podocyte-associated protein that play key roles in maintaining the structural and functional integrity of the kidney's filtration barrier. The shedding of nephrin reflects compromisation of podocytes' functional and structural integrity.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients diagnosed to have inflammatory bowel disease (ulcerative colitis or chron's disease )with age more than 18 years and normal kidney function test

Exclusion Criteria:

Patients known to have renal disease due to other causes . Diabetic patients . Hypertensive patients

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Diagnostic Test:
• urinary nephrin and alpha one microglobulin
urinary nephrin and alpha one microglobulin are biomarkers of glomerular filtration barrier injury and tubular injury respectively measured by ELISA

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

Akankwasa G, Jianhua L, Guixue C, Changjuan A, Xiaosong Q. Urine markers of podocyte dysfunction: a review of podocalyxin and nephrin in selected glomerular diseases. Biomark Med. 2018 Aug;12(8):927-935. doi: 10.2217/bmm-2018-0152. Epub 2018 Jul 6. Review. — View Citation

Chang CJ, Wang PC, Huang TC, Taniguchi A. Change in Renal Glomerular Collagens and Glomerular Filtration Barrier-Related Proteins in a Dextran Sulfate Sodium-Induced Colitis Mouse Model. Int J Mol Sci. 2019 Mar 22;20(6). pii: E1458. doi: 10.3390/ijms20061458. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early detection of renal injury in patients diagnosed to have inflammatory bowel disease with normal kidney function	using urinary biomarkers (nephrin and alpha one microglobulin ) for early detection of renal injury in inflammatory bowel disease patients	baseline