Urinary Biomarkers of Renal Injury in Inflammatory Bowel Disease

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

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 .

Study Overview

• Status: Unknown
• Conditions: Inflammatory Bowel Diseases
• Intervention / Treatment: Diagnostic test: urinary nephrin and alpha one microglobulin

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Noha G Abdelmalik; Phone Number: 01005509890; Email: nohagamalmalik@gmail.com
• Study Contact Backup: Name: Wael A Abbas; Phone Number: 01064236064; Email: Drwaelabbas@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

inflammatory bowel disease patients aging more than 18 with no concomitent kidney disease

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with chron's disease	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
patients with ulcerative cholitis	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.
• 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):1458. doi: 10.3390/ijms20061458.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: February 21, 2020
• First Submitted That Met QC Criteria: February 24, 2020
• First Posted (Actual): February 25, 2020

Study Record Updates

• Last Update Posted (Actual): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 24, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: Kidney in IBD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No