Urinary Congophilia As an Indicator of Activity of Lupus Nephritis

NCT06654024 | Not Yet Recruiting DMC

• 1 other identifier: urinary congophilia in LN
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lupus Nephritis (LN)

Keywords

congophilia; lupus nephritis; congo red

Outcome Measures

Primary Outcomes (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.

  baseline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• \- 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 )

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit University ,Faculty of Medicine

Assute, Assute, 71516, Egypt

Location

Related Publications (12)

• 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.

  BACKGROUND

• 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.

  PMID: 31779843 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 36864848 BACKGROUND

• 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.

  PMID: 25031267 BACKGROUND

• 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.

  PMID: 30177078 BACKGROUND

• 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.

  PMID: 22566930 BACKGROUND

• 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.

  PMID: 32500443 BACKGROUND

• 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.

  PMID: 36864291 BACKGROUND

• 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.

  PMID: 33280015 BACKGROUND

• 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.

  PMID: 36774306 BACKGROUND

• 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.

  PMID: 38182286 BACKGROUND

MeSH Terms

Conditions

Lupus Nephritis

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Radwa Awad Abdelhafiz, PhD doctorate

  assuit university, faculty of medicine

  STUDY DIRECTOR

• Samir Kamal Abd elhameed, Professor

  assuit university, faculty of medicine

  STUDY DIRECTOR

Central Study Contacts

ali setohy hussien, has master degree

CONTACT

+2001020462809; Setohy94@aun.edu.eg

Radwa Awad Abdelhafiz, PhD doctorate

CONTACT

+2001003797448; radwaawad@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 23, 2024
• Study Start: December 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)