SSerum/Urinary Monocyte Chemoattractant Protein-1 Level as a Marker for Lupus Nephritis

Serum/Urinary Monocyte Chemoattractant Protein-1 Level as a Marker for Lupus Nephritis

Systemic lupus erythematosus (SLE) is a chronic inflammatory autoimmune disease affecting many organ systems. SLE includes a wide spectrum of severity, ranging from relatively mild manifestations (e.g. skin rash or non-erosive arthritis) to seriously disabling or even life threatening complications, such as lupus nephritis (LN) and neuropsychiatric disorders . LN is one of the most serious SLE complications since it is the major predictor of poor prognosis .

Lupus nephritis is a common major organ manifestation and main cause of morbidity and mortality of the disease . It is occurred in 30-50% of SLE patients at initial diagnosis and more prevalent in Asians and Blacks than other races . Approximately, 10-30% of LN patients will develop the end-stage renal disease (ESRD) within 15 years after diagnosis. The 5-year survival rate of a patient with severe LN is less than70-80%. Therefore, an involvement of renal disease activity is one of the most important prognostic factors for patients with SLE, and the diagnosis of SLE patients with LN has an important clinical implication in guiding the treatment of SLE in clinical settings.

Study Overview

• Status: Unknown
• Conditions: Systemic Lupus

Detailed Description

Systemic lupus erythematosus (SLE) is a chronic inflammatory autoimmune disease affecting many organ systems. SLE includes a wide spectrum of severity, ranging from relatively mild manifestations (e.g. skin rash or non-erosive arthritis) to seriously disabling or even life threatening complications, such as lupus nephritis (LN) and neuropsychiatric disorders . LN is one of the most serious SLE complications since it is the major predictor of poor prognosis .

Lupus nephritis is a common major organ manifestation and main cause of morbidity and mortality of the disease. It is occurred in 30-50% of SLE patients at initial diagnosis and more prevalent in Asians and Blacks than other races . Approximately, 10-30% of LN patients will develop the end-stage renal disease (ESRD) within 15 years after diagnosis. The 5-year survival rate of a patient with severe LN is less than70-80% . Therefore, the diagnosis of SLE patients with LN has an important clinical implication in guiding the treatment of SLE in clinical settings.

Renal biopsies have remained the "gold standard" of assessing lupus nephritis (LN) patients not only at diagnosis but also to assess the efficacy of treatment. In contrast, current noninvasive laboratory markers for LN such as proteinuria, urine protein to creatinine ratio, creatinine clearance, antidsDNA, and complement levels are unsatisfactory because they lack sensitivity and specificity for differentiating renal activity and damage in LN.

The search for an accurate and reliable biomarker for lupus nephritis is particularly important since the only reliable method to evaluate it is by performing a kidney biopsy, that is an invasive procedure may not always be feasible. So significant effort has been put into identifying biomarkers that can anticipate impending lupus renal flare, forecast development of chronic kidney disease, or reflect kidney histology at time of flare .

Monocyte chemoattractant protein-1 (MCP1) is a chemokine that attracts monocytes/macrophages to sites of inflammation. MCP-1 is produced by mesangial, podocyte, and monocyte cells in response to various proinflammatory stimuli such as tumor necrosis factor alpha (TNF-

• Study Type: Observational
• Enrollment (Anticipated): 60

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This study will include 60 patients with renal biopsy proven LN or without LN by laboratory investigation together with 20 healthy control age and sex matched with the patients.

Description

Inclusion Criteria:

• revised American Collage of Rheumatology classification criteria for SLE

Exclusion Criteria:

• Patients with diabetes mellitus.
• patients with a diagnosis of overlap syndrome (coexistence of lupus with other connective tissue diseases such as rheumatoid arthritis or scleroderma)..
• Patients with urinary tract infection.
• Patients with end stage renal disease.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum/Urinary monocyte chemoattractant protein-1 level as a marker for lupus nephritis	- Determine the levels of serum / urinary MCP-1 in patients with systemic lupus erythematosus	one year

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2019
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: May 22, 2017
• First Submitted That Met QC Criteria: May 22, 2017
• First Posted (Actual): May 24, 2017

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 12, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Kidney Diseases; Urologic Diseases; Connective Tissue Diseases; Glomerulonephritis; Lupus Erythematosus, Systemic; Nephritis; Lupus Nephritis
• Other Study ID Numbers: assiut 8080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: use Serum/Urinary monocyte chemoattractant protein-1 level as a marker for lupus nephritis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No