Actively Recruiting

Age: 16Years - 60Years
All Genders
Healthy Volunteers
NCT06167174

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

Led by Chinese SLE Treatment And Research Group · Updated on 2023-12-12

100

Participants Needed

1

Research Sites

261 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 16Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 16 and 60 years
  • Diagnosed with systemic lupus erythematosus (SLE) according to the 2012 SLICC classification
  • Kidney biopsy classified as class III, IV, V+III, or V+IV within the past 6 months
  • Kidney biopsy shows active lupus nephritis disease
  • Two 24-hour urine protein tests within two weeks showing greater than 1 gram each
  • Never received glucocorticoids or immunosuppressants, or received standard treatment for more than 1 month without changes
  • Standard treatment includes prednisone 0-20 mg/day or equivalent glucocorticoids, and acceptable immunosuppressants within specified dose limits
  • Provided informed consent
Not Eligible

You will not qualify if you...

  • Having other connective tissue or autoimmune diseases
  • Having neuropsychiatric lupus, alveolar hemorrhage, retinal lesions, pulmonary arterial hypertension, or other severe organ involvement
  • Pregnant or breastfeeding women
  • Current infections requiring antibiotic or antiviral treatment
  • Having other kidney diseases
  • Platelet count less than 50 x 10^9/L
  • Elevated liver enzymes (ALT or AST) greater than 1.5 times normal upper limit
  • Elevated total bilirubin or blood lipid levels greater than 2 times normal upper limit
  • Any other condition deemed unsuitable for study participation by the investigators

AI-Screening

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Trial Site Locations

Total: 1 location

1

Peking Union Medical College Hospital

Beijing, China

Actively Recruiting

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Research Team

X

Xinping Tian, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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