Urine Exosomes to Identify Biomarkers for LN

• Conditions: Lupus Nephritis
• Interventions: Diagnostic Test: biomarkers detection in different groups

• Registration Number: NCT04894695
• Lead Sponsor: RenJi Hospital

Brief Summary

Urine exosomes will be extracted from patients with lupus nephritis, healthy controls, and patients with systemic lupus erythematosus without lupus nephritis. Transcriptome and/or metabonomics sequencing of exosomes will be performed to screen for molecules in the urine exosomes of patients with lupus nephritis that are significantly different from those of the other groups.

Detailed Description

Lupus nephritis is one of the most common complications of SLE, and its severity is closely related to the prognosis of SLE. The gold standard for diagnosing lupus nephritis depends on the pathological results of a kidney biopsy, which is invasive and may cause some damage to the patient. Exosomes exist in almost all types of body fluids such as serum, urine and cerebrospinal fluid, and contain a variety of genetic materials and proteins secreted by cells, such as miRNA, lnRNA, cirRNA and metabolites, etc., which are potential substances that can be used as biomarkers of diseases discovered in recent years. Urine exosomes are easy to obtain and have no impact on patients' health, making them suitable for study as disease biomarkers for lupus nephritis.

In this study, urine exosomes will be extracted from patients with lupus nephritis, healthy controls, and patients with systemic lupus erythematosus without lupus nephritis. Transcriptome and/or metabonomics sequencing of exosomes will be performed to screen for molecules in the urine exosomes of patients with lupus nephritis that are significantly different from those of the other groups.

Study Timeline

• Study Start: 2020-08-02
• Status Verified: 2021-05
• Study First Submitted: 2021-05-15
• Study First Submitted QC: 2021-05-15
• Study First Posted: 2021-05-20
• Last Update Submitted: 2021-07-27
• Last Update Posted: 2021-08-03
• Primary Completion: 2021-08-30
• Study Completion: 2021-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• No history of chronic or serious diseases such as cardiovascular disease, liver disease, kidney disease, respiratory disease, blood disease, lymphatic disease, endocrine disease, immune disease, mental disease, neuromuscular disease, gastrointestinal system disease, etc.
• General health condition is good;
• Vital signs examination, physical examination, clinical laboratory examination (blood routine, urine routine, blood biochemical examination, coagulation function examination), electrocardiogram, and the results show normal or abnormal without clinical significance

Exclusion Criteria

• Other rheumatic immune disease;
• Abnormal liver and kidney function;
• Acute and chronic infectious diseases.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy control (HC)	biomarkers detection in different groups	healthy control
lupus nephritis (LN)	biomarkers detection in different groups	lupus nephritis
Systemic Lupus Erythematosus (SLE)	biomarkers detection in different groups	Systemic Lupus Erythematosus

Primary Outcome Measures

Name	Time	Method
specific molecule levels in urine exosomes	2 weeks	Molecule like miRNAs were determined in urine exosomes of different groups and the following validation will determine which molecule can be served as biomarkers of lupus nephritis

Trial Locations

Locations (1)

Renji Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, China