Urine Exosomes to Identify Biomarkers for LN

Lupus Nephritis Clinical Trial

Official title:

Identification of Biomarkers for Lupus Nephritis Using Urine Exosomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04894695
• Other study ID #: urine exo-LN
• Status: Recruiting
• Start date: August 2, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: May 2021
• Source: RenJi Hospital
• Contact: Huijing Huang
• Phone: 86-18217720058
• Email: fangfeijin90[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: August 31, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Diagnostic Test:
• biomarkers detection in different groups
Biomarkers of urine exosomes in different groups were identified by sequencing technology,then biomarkers were validated using urine samples of different groups

Locations

Country	Name	City	State
China	Renji Hospital, Shanghai Jiaotong University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Zhao Y, Wei W, Liu ML. Extracellular vesicles and lupus nephritis - New insights into pathophysiology and clinical implications. J Autoimmun. 2020 Dec;115:102540. doi: 10.1016/j.jaut.2020.102540. Epub 2020 Sep 4. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	specific molecule levels in urine exosomes	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	2 weeks