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

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 60
Healthy Volunteers: t
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• 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.

• 24-hour urinary protein was tested twice within two weeks, both of which were greater than 1g.

• The patients have never received glucocorticoid/immunosuppressants or received standard treatment for more than 1 month without change. The standard treatment should fulfill: a. prednisone 0-20mg/day, or equivalent other glucocorticoids; b. acceptable immunosuppressants, including Tacrolimus ≤ 4mg/d, methotrexate ≤ 15mg/week, azathioprine ≤ 100mg/d and MMF ≤ 1g/d.

• Informed consent obtained.

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
Xinping Tian, MD
tianxp6@126.com
86-13691165939
Time Frame
Start Date: 2023-12-05
Estimated Completion Date: 2028-12-05
Participants
Target number of participants: 100
Treatments
MMF treatment
Patients that have been diagnosed as III/IV ± V LN and treated with MMF 2g/d in combination with glucocorticoid.
CYC treatment
Patients that have been diagnosed as III/IV ± V LN and treated with CYC 0.5g IV per two weeks in combination with glucocorticoid.
Sponsors
Leads: Chinese SLE Treatment And Research Group

This content was sourced from clinicaltrials.gov