Urinary Congophilia As an Indicator of Activity of Lupus Nephritis (lupus nephriti)

December 11, 2024 updated by: Ali Setohy Hussein Ali, Assiut University

Assessment of Urinary Congophilia As an Indicator of Disease Activity of Lupus Nephritis

Evaluation of the impact of SLE on urinary levels of congophilia and their relationship to renal histopathology and activity of lupus nephritis (LN)

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Systemic lupus erythematosus (SLE) is an inflammatory autoimmune disease that can affect all body organs. The reported lifetime incidence of lupus nephritis (LN) in SLE patients is 20%- 60% and it is histologically evident in most SLE patients, even without clinical manifestations of kidney disease .

Lupus nephritis is associated with higher mortality , as within 5 years of diagnosis, between 10 and 30 percent of these people develop end-stage renal disease . Early detection and treatment of lupus nephritis can significantly improve renal outcomes and decrease overall mortality .

Endoplasmic reticulum (ER) stress proteins, which act as protein quality control factors in the secretory pathway in the cell are induced by ER stress in inflammatory lesions, and also participate in autoimmunity and inflammation processes, ER stress proteins are expressed not only in the ER but also occasionally at the cell surface that plays pathophysiological roles in autoimmune and inflammatory diseases as pro- or anti-inflammatory factors, Protein folding is easily impaired (misfolding) by different cytotoxic stresses as inflammation or hypoxia , that may contribute to disease pathogenesis by either reducing the biological activity of the protein or due to toxicity by the misfolded proteins, The detection of the abnormally misfolded proteins using the Congo red stain is referred to as congophilia, Urinary congophilia was assessed by Congo Red Dot Blot (CRDB) Assay Congo red is a synthetic diazo dye with specific affinity for β-sheets of amyloid fibrils of misfolded proteins, In addition to the simplicity of congophilia based dot blot technique, the non-invasiveness of the method is useful in adapting the CRDB assay for self-collected urine samples.

One previous study in pregnant females with lupus nephritis said that urinary congophilia has a diagnostic value in patients with lupus nephritis and can be used as a reliable marker of disease activity as the presence of urinary congophilia biomarker is related to disease activity rather than pregnancy.

Study Type

Observational

Enrollment (Estimated)

74

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

  • Name: ali setohy hussien, has master degree
  • Phone Number: +2001556167206 +2001020462809
  • Email: Setohy94@aun.edu.eg

Study Contact Backup

  • Name: Radwa Awad Abdelhafiz, PhD doctorate
  • Phone Number: +2001003797448
  • Email: radwaawad@aun.edu.eg

Study Locations

  • Egypt
      • Assute, Egypt, 71516
        • Assuit University ,Faculty of Medicine
        • Contact:

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

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients ≥ 18 years old that were diagnosed with SLE according to EULAR/ACR classification criteria 2019 for SLE, and lupus nephritis based on renal biopsy or active urinary sediment (proteinuria or hematuria ) ,all are included in this study

Description

Inclusion Criteria:

- Adult patients ≥ 18 years old that were diagnosed with SLE according to EULAR/ACR classification criteria 2019 for SLE, and lupus nephritis based on renal biopsy or active urinary sediment (proteinuria or hematuria )

Exclusion Criteria:

  • Any patient has evidence of nephritis that may cause proteinuria as diabetes mellitus and any other causes of glomerulonephritis other than lupus nephritis
  • pregnant females with lupus nephritis and hypertensive disorders

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
urinary congophilia level in patient with lupus nephritis is a marker for disease activity
Time Frame: baseline
Urinary congophilia levels increase in patients with lupus nephritis so that it can be used as a non-invasive urinary marker of lupus nephritis activity.
baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Director: Radwa Awad Abdelhafiz, PhD doctorate, assuit university, faculty of medicine
  • Study Director: Samir Kamal Abd elhameed, Professor, assuit university, faculty of medicine

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 (Estimated)

December 1, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

October 21, 2024

First Submitted That Met QC Criteria

October 21, 2024

First Posted (Actual)

October 23, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 11, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • urinary congophilia in LN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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