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Urine Exosomes to Identify Biomarkers for LN

Identification of Biomarkers for Lupus Nephritis Using Urine Exosomes

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04894695
Enrollment
400
Registered
2021-05-20
Start date
2020-08-02
Completion date
2021-08-31
Last updated
2021-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus Nephritis

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.

Interventions

DIAGNOSTIC_TESTbiomarkers 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

Sponsors

RenJi Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
specific molecule levels in urine exosomes2 weeksMolecule 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

Countries

China

Contacts

Primary ContactHuijing Huang
fangfeijin90@163.com86-18217720058

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026