Urine Exosomes to Identify Biomarkers for LN

Phase

N/A

Condition

Lupus Nephritis

Kidney Disease

Nephritis

Treatment

N/A

Clinical Study ID

NCT04894695

urine exo-LN

All Genders
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

No history of chronic or serious diseases such as cardiovascular disease, liverdisease, 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 (bloodroutine, urine routine, blood biochemical examination, coagulation functionexamination), electrocardiogram, and the results show normal or abnormal withoutclinical significance

Exclusion

Exclusion Criteria:

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

Study Design

August 02, 2020

August 31, 2021

Study 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.

Connect with a study center

Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 021
China
Active - Recruiting

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