TF, TFPI and Plasmin as Novel Bio-markers in Early Diagnosis of Lupus Nephritis

NCT04218890 | Unknown DMC

• 1 other identifier: ASA2
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Urinary levels of plasmin ,TF , and TFPI are all elevated in active LN patients compared to inactive LN patients and healthy controls. All four proteins correlated with systemic disease activity and renal disease activity. Importantly, urine plasmin performed best among the four proteins in discriminating active LN from inactive disease, even better than traditional markers, such as anti ds DNA and complement C3. Furthermore, the combination of urine plasmin and TFPI showed higher specificity and negative predictive values than urine plasmin when compared to anti-ds DNA and complement C3

Conditions

Lupus Nephritis

Outcome Measures

Primary Outcomes (2)

• The diagnostic utility of tissue factor ,, tissue factor pathway inhibitor and plasmin as biomarkers for early detection of lupus nephritis (LN)

  Urinay sample of 100 subjects (80 with SLE ,40 of them with LN,and 20 are healthy persons)will be collected as a morning sample\& using ELISA test to detect the level of these bio-markers in the urine of these subjects

  2023

• the correlation of these bio-markers to the clinical staging , the disease activity index and revised treatment .

  correlate the level of the markers with the renal biopsy staging and activity index using (International Society of Nephrology /Renal Pathology Society classification (ISN/RPS), and disease Activity Index (SLEDAI-2K \& r SLEDAI)).

  2023

Study Arms (3)

SLE patients without lupus nephritis

40 SLE patients 40SLE patients( All SLE pt. satisfied the ACR criteria for SLE diagnosis) these patients will be without any evidences of nephritis

Diagnostic Test: Urinary tissue factor (TF), tissue factor pathway inhibitor (TFPI) and plasmin

SLE patients with lupus nephritis

40SLE patients with evidences of nephritis

Diagnostic Test: Urinary tissue factor (TF), tissue factor pathway inhibitor (TFPI) and plasmin

healthy control group

20 healthy subjects matched age and sex with be enrolled as healthy control group

Diagnostic Test: Urinary tissue factor (TF), tissue factor pathway inhibitor (TFPI) and plasmin

Interventions

Urinary tissue factor (TF), tissue factor pathway inhibitor (TFPI) and plasmin DIAGNOSTIC_TEST

urinary sample

SLE patients with lupus nephritis; SLE patients without lupus nephritis; healthy control group

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Clinical data will be gathered and SLEDAI will be calculated based on chart review .SLE patients will then classified as having either active LN (ALN) or inactive LN (ILN). Active LN is defined as active urine sediment or proteinuria (rSLEDAI \> 0). Inactive LN is defined as inactive urine sediment and no proteinuria (rSLEDAI = 0).

You may qualify if:

• age \>15 years
• SLE patients fullfiling ACR diagnostic criteria

You may not qualify if:

• Renal artery stenosis, congenital renal diseases ,renal tumor,other causes of GN
• Pregnancy.
• coagulation disorders
• DM,HTN and the other connective tissue disease
• Obesity
• CKD

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• Qin L, Stanley S, Ding H, Zhang T, Truong VTT, Celhar T, Fairhurst AM, Pedroza C, Petri M, Saxena R, Mohan C. Urinary pro-thrombotic, anti-thrombotic, and fibrinolytic molecules as biomarkers of lupus nephritis. Arthritis Res Ther. 2019 Jul 18;21(1):176. doi: 10.1186/s13075-019-1959-y.

  PMID: 31319876 BACKGROUND

• Frijns R, Fijnheer R, Schiel A, Donders R, Sixma J, Derksen R. Persistent increase in plasma thrombomodulin in patients with a history of lupus nephritis: endothelial cell activation markers. J Rheumatol. 2001 Mar;28(3):514-9.

  PMID: 11296951 BACKGROUND

• Ding H, Kharboutli M, Saxena R, Wu T. Insulin-like growth factor binding protein-2 as a novel biomarker for disease activity and renal pathology changes in lupus nephritis. Clin Exp Immunol. 2016 Apr;184(1):11-8. doi: 10.1111/cei.12743. Epub 2016 Jan 11.

  PMID: 26616478 BACKGROUND

• Petri M, Kasitanon N, Lee SS, Link K, Magder L, Bae SC, Hanly JG, Isenberg DA, Nived O, Sturfelt G, van Vollenhoven R, Wallace DJ, Alarcon GS, Adu D, Avila-Casado C, Bernatsky SR, Bruce IN, Clarke AE, Contreras G, Fine DM, Gladman DD, Gordon C, Kalunian KC, Madaio MP, Rovin BH, Sanchez-Guerrero J, Steinsson K, Aranow C, Balow JE, Buyon JP, Ginzler EM, Khamashta MA, Urowitz MB, Dooley MA, Merrill JT, Ramsey-Goldman R, Font J, Tumlin J, Stoll T, Zoma A; Systemic Lupus International Collaborating Clinics. Systemic lupus international collaborating clinics renal activity/response exercise: development of a renal activity score and renal response index. Arthritis Rheum. 2008 Jun;58(6):1784-8. doi: 10.1002/art.23456.

  PMID: 18512819 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

Central Study Contacts

Salwa Salah Elgendy, professor dr

CONTACT

01005766155; salwaelgendi@yahoo.com

Effat Abdelhady Eltony

CONTACT

01097330309; effattony@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: December 28, 2019
• First Posted: January 6, 2020
• Study Start: April 1, 2020
• Primary Completion: April 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 7, 2020

Record last verified: 2020-01