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

NCT03164720 | Unknown DMC

• 1 other identifier: assiut 8080
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Systemic Lupus

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• revised American Collage of Rheumatology classification criteria for SLE

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assiut

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 24, 2017
• Study Start: June 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2022
• Last Updated: January 15, 2019

Record last verified: 2019-01