Renal Involvement in Inflammatory Bowel Disease Patients

June 4, 2021 updated by: Hend Hamdy Tawfik Abdelhakim, Assiut University

Evaluation of Renal Involvement in Inflammatory Bowel Disease Patients

To evaluate renal involvement in inflammatory bowel disease patients .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Inflammatory bowel disease (IBD) is a chronic, relapsing and remitting inflammatory condition predominantly affecting the gastrointestinal (GI) tract that results from complex interplay of the individual's genetic makeup, the environment, the gut microbiota and the host immune response .

IBD is an umbrella disorder that covers Crohn's disease, ulcerative colitis and IBD unclassified . Crohn's disease is characterised by transmural inflammation that can affect any part of the GIT with characteristic skip lesions of healthy tissues, while ulcerative colitis is a continuous mucosal inflammation largely confined to the colon. 'IBD unclassified' is a term used when the endoscopic and histological features are not sufficient to favour one of the other diagnoses.

The prevalence of extraintestinal manifestations (EIMs) in inflammatory bowel diseases (IBDs) varies from 6%-46%.

The mechanisms that have been suggested include contributions of genetic factors, infectious agents, circulating bacterial endotoxins and immune-complex deposition.

EIMs can involve almost every organ system. It is not always possible to identify the pathophysiological mechanism underlying an organ's involvement in IBD; it may originate from the same pathophysiological mechanism as intestinal disease, or as a secondary complication of IBDs, Renal involvement has been considered as an EIM and has been described both in Crohn's disease (CD) and in ulcerative colitis (UC).

Renal EIMs and IBD-related therapy are potential risk factors for the development of renal insufficiency (both acute and chronic) in patients with CD and UC.

Chronic kidney disease (CKD) is a type of kidney disease in which there is gradual loss of kidney function over a period of months to years.

CKD is defined as kidney damage or glomerular filtration rate (GFR) <60 ml /min/1.73 m2 for 3 months or more .

GFR can be estimated from calibrated serum creatinine and estimating equations ,such as the Modification of Diet in Renal Disease (MDRD) study equation or the Cockcroft -Gault formula .

Kidney disease severity is classified into five stages according to the level of GFR.

  1. Stage 1: Slightly diminished function; kidney damage with normal or relatively high GFR (≥90 ml/min/1.73 m2)
  2. Stage 2: Mild reduction in GFR (60-89 ml/min/1.73 m2) with kidney damage
  3. Stage 3: Moderate reduction in GFR (30-59 ml/min/1.73 m2)
  4. Stage 4: Severe reduction in GFR (15-29 ml/min/1.73 m2)
  5. Stage 5: Established kidney failure (GFR <15 ml/min/1.73 m2)

The most frequent renal diseases in patients with IBD are: nephrolithiasis, tubulointerstitial nephritis, glomerulonephritis and amyloidosis .

As in other EIMs, renal manifestations can be considered as dependent on the same immunological mechanism that determines intestinal inflammatory diseases, directly related to intestinal activity. Another hypothesis to be considered is that renal involvement is an independent of bowel disease, due to its autoimmune mechanism of action; otherwise, it could be related to metabolic disorders that develop in IBD. Finally, kidney pathologies in IBD have been associated with side e!ects of drugs Aminosalicylates, azathioprine, cyclosporin and TNFα inhibitors may be involved in renal impairment. However, it is not always possible to clarify the mechanism of these drugs in kidney damage. In many cases it remains unclear whether renal impairment is an EIM or a drug adverse effect

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Minya, Egypt
        • Recruiting
        • Hend Hamdy Tawfik
        • Contact:
          • Hend H Tawfik, Res
          • Phone Number: 00201226253775

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

cohort study

Description

Inclusion Criteria:

  • patients with IBD diagnosed by colonoscopy and histopathology will classify the activity of the case to mild ,moderate and severe according to Mayo classification and have renal problems .
  • Age (18 - 65 years)

Exclusion Criteria:

  • patients underage of 18
  • HCV or HBV patients
  • renal patients diagnosed before diagnosis of IBD
  • diabetic or hypertensive patients
  • other autoimmune diseases such as Rheumatoid Arthritis, SLE.
  • Malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IBD Patients with Renal Involvement

  1. Inclusion criteria: - patients with IBD diagnosed by colonoscopy and histopathology will classify the activity of the case to mild ,moderate and severe according to Mayo classification and have renal problems .

    Age (18-65 years)

  2. Exclusion criteria: 1-patients underage of 18 2-HCV or HBV patients 3- renal patients diagnosed before diagnosis of IBD 4- diabetic or hypertensive patients 5- other autoimmune diseases such as Rheumatoid Arthritis, SLE. 6- Malignancy
Other: Medical tests
Blood tests
IBD Patients without Renal Involvement

  1. Inclusion criteria: - patients with IBD diagnosed by colonoscopy and histopathology will classify the activity of the case to mild ,moderate and severe according to Mayo classification and have no renal problems .

    Age (18-65 years)

  2. Exclusion criteria: 1-patients underage of 18 2-HCV or HBV patients 3- renal patients diagnosed before diagnosis of IBD 4- diabetic or hypertensive patients 5- other autoimmune diseases such as Rheumatoid Arthritis, SLE. 6- Malignancy
Other: Medical tests
Blood tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation between lab, radiological and colonoscopy
Time Frame: Baseline

All patients will be subjected to full clinical history , examination and investigation

.investigations will include:

A-Laboratory tests:

  • CBC
  • urine analysis
  • calculating the estimated glomerular filtration rate (eGFR)
  • 24hr urinary protein
  • hepatitis markers ,liver function tests
  • kidney function tests.
  • -kidney biopsy for patients with renal involvement if needed
  • ANA, Anti ds
  • blood electrolyte ( Na, K, Ca , Mg ) B- Radiological: abdominal ultrasonography C- colonoscopy . to evaluate renal ivolvement in inflammatory bowel disease
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Enas A Reda Alkaremy, Prof, Alkareemy@yahoo.com

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

March 3, 2021

First Submitted That Met QC Criteria

June 4, 2021

First Posted (Actual)

June 10, 2021

Study Record Updates

Last Update Posted (Actual)

June 10, 2021

Last Update Submitted That Met QC Criteria

June 4, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBD impacts on kidney

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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