Exploring Biomarkers for Therapeutic Response of Lupus Nephritis Based on Multi Omics Analysis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-60
SponsorChinese SLE Treatment And Research Group

About this trial

This is an observational study of patients with lupus nephritis aiming to find biomarkers that can predict patients' response to immunosuppressants. We planed to collect 100 lupus nephritis patients' peripheral blood,kidney tissues and urine before and after treatment (mycophenolate mofetil or cyclophosphamide, in combination with glucocorticoids). Then multi omics analysis, including single cell RNA-seq, ATAC-seq and CITE-seq, will be performed to find new biomarkers for patients' response and prognosis.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age between 16-60 years.

Fulfilling the 2012 SLICC classification for SLE.

Renal biopsy pathology was clearly classified as III \ IV \ V+III \ V+IV within 6 months.

Renal biopsy reveals active disease.

Disqualifiers

Other concomitant connective tissue diseases or autoimmune diseases.

Neuropsychiatric lupus, alveolar hemorrhage, retinal lesions, pulmonary arterial hypertension, or other severe organ involvement.

Pregnant or lactating women.

Current infections that require antibiotic or antiviral treatment.

Trial population

All patients visit Rheumatology and Immunology Department of Peking Union Medical College Hospital and fulfill the inclusion criteria.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: MMF treatment
Group B: CYC treatment

Trial outcomes

Primary outcomes

1

Treatment response of patients

The proportion of patients who achieve complete response, partial response or no response 24 weeks after baseline

Time frame
24 weeks

Secondary outcomes

1

Disease progression

Clinical indices that can indicate the progression of disease, including 24-hour urinary protein, routine urine and blood tests, immune indices and patients' syndromes, will be evaluated at 4, 12, 24 weeks after baseline to monitor the progression of lupus nephritis.

Time frame
24 weeks
2

Adverse events during the study

All adverse events, severe adverse events and proportion of patients who discontinued the treatment due to adverse events within the duration of the study.

Time frame
24 weeks

Other outcomes

Sponsors and contacts

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