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Lupus Nephritis (LN)lupus nephritiNCT06654024

Urinary Congophilia as an Indicator of Activity of Lupus Nephritis

An observational study of Lupus Nephritis (LN), run by Assiut University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Lupus Nephritis (LN)
How many people
74 participants
Where
1 siteEgypt
Study dates
Dec 2024to Feb 2026
How long will I take part?
1 Month
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

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

Who may be able to join

  • 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 )

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

ali setohy hussien, has master degree contact

+2001020462809 ext. +2001556167206

Setohy94@aun.edu.eg

Radwa Awad Abdelhafiz, PhD doctorate contact

+2001003797448

radwaawad@aun.edu.eg

Egypt1 site

  • Assuit University ,Faculty of Medicine

    Assute, Assute, 71516

    ali S hussien, 01020462809, setohy94@gmail.com

Other trials in Egypt

About this study

Official title: 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)

Read the 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.

Keywords
congophilia, lupus nephritis, congo red
Medical subject headings
Lupus Nephritis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. urinary congophilia level in patient with lupus nephritis is a marker for disease activity

    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.

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2024
  2. Study startDec 2024 (estimated)
  3. Primary completionJan 2026 (estimated)
  4. Study completionFeb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Cross-sectional
Enrolment
74 participants (estimated)
Target duration
1 Month
IDs, dates and publications
ClinicalTrials.gov ID
NCT06654024
Sponsor's protocol ID
urinary congophilia in LN
Acronym
lupus nephriti
Status last verified
Dec 2024
First submitted
21 Oct 2024
Last updated
16 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Prasanwong T, Laoharojvongsa N, Pongpanich K, Satirapoj B, Charoenpitakchai M. Pathological assessment of activity and chronicity indices in lupus nephritis patients. Asian Arch Path. 2020;2:3-13.

  • Aringer M. EULAR/ACR classification criteria for SLE. Semin Arthritis Rheum. 2019 Dec;49(3S):S14-S17. doi: 10.1016/j.semarthrit.2019.09.009.

    PubMed 31779843

  • Younis D, Shemies RS, El-Kannishy G, Mosbah A, Zakaria M, Awadalla A, et al. # 5383 THE PREDICTIVE VALUE OF URINARY CONGOPHILIA AS A BIOMARKER IN PREGNANT AND NON-PREGNANT WOMEN WITH LUPUS NEPHRITIS. Nephrology Dialysis Transplantation.

  • Khaliq OP, Phoswa WN, Moodley J. The effectiveness of the Congo Red Dot paper test in hypertensive disorders of pregnancy: A systematic review and meta-analysis. Front Reprod Health. 2023 Feb 13;5:1120937. doi: 10.3389/frph.2023.1120937. eCollection 2023.

    PubMed 36864848

  • Buhimschi IA, Nayeri UA, Zhao G, Shook LL, Pensalfini A, Funai EF, Bernstein IM, Glabe CG, Buhimschi CS. Protein misfolding, congophilia, oligomerization, and defective amyloid processing in preeclampsia. Sci Transl Med. 2014 Jul 16;6(245):245ra92. doi: 10.1126/scitranslmed.3008808.

    PubMed 25031267

  • Nagarajappa C, Rangappa SS, Suryanarayana R, Balakrishna S. Urinary congophilia in preeclampsia: Experience from a rural tertiary-care hospital in India. Pregnancy Hypertens. 2018 Jul;13:83-86. doi: 10.1016/j.preghy.2018.05.006. Epub 2018 May 14.

    PubMed 30177078

  • Morito D, Nagata K. ER Stress Proteins in Autoimmune and Inflammatory Diseases. Front Immunol. 2012 Mar 15;3:48. doi: 10.3389/fimmu.2012.00048. eCollection 2012.

    PubMed 22566930

  • Kostopoulou M, Adamichou C, Bertsias G. An Update on the Diagnosis and Management of Lupus Nephritis. Curr Rheumatol Rep. 2020 Jun 4;22(7):30. doi: 10.1007/s11926-020-00906-7.

    PubMed 32500443

  • Mok CC, Teng YKO, Saxena R, Tanaka Y. Treatment of lupus nephritis: consensus, evidence and perspectives. Nat Rev Rheumatol. 2023 Apr;19(4):227-238. doi: 10.1038/s41584-023-00925-5. Epub 2023 Mar 2.

    PubMed 36864291

  • Gasparotto M, Gatto M, Binda V, Doria A, Moroni G. Lupus nephritis: clinical presentations and outcomes in the 21st century. Rheumatology (Oxford). 2020 Dec 5;59(Suppl5):v39-v51. doi: 10.1093/rheumatology/keaa381.

    PubMed 33280015

  • Zen M, Salmaso L, Barbiellini Amidei C, Fedeli U, Bellio S, Iaccarino L, Doria A, Saia M. Mortality and causes of death in systemic lupus erythematosus over the last decade: Data from a large population-based study. Eur J Intern Med. 2023 Jun;112:45-51. doi: 10.1016/j.ejim.2023.02.004. Epub 2023 Feb 9.

    PubMed 36774306

  • Kidney Disease: Improving Global Outcomes (KDIGO) Lupus Nephritis Work Group. KDIGO 2024 Clinical Practice Guideline for the management of LUPUS NEPHRITIS. Kidney Int. 2024 Jan;105(1S):S1-S69. doi: 10.1016/j.kint.2023.09.002. No abstract available.

    PubMed 38182286

Questions about this trial

What is this clinical trial studying?

An observational study of Lupus Nephritis (LN), run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ali setohy hussien, has master degree (+2001020462809 ext. +2001556167206, Setohy94@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

urinary congophilia level in patient with lupus nephritis is a marker for disease activity (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06654024, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.

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