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

Last updated: December 4, 2023
Sponsor: Chinese SLE Treatment And Research Group
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lupus Nephritis

Kidney Disease

Nephritis

Treatment

N/A

Clinical Study ID

NCT06167174
CSTAR-K2939
  • Ages 16-60
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Age between 16-60 years.
  2. Fulfilling the 2012 SLICC classification for SLE.
  3. Renal biopsy pathology was clearly classified as III \ IV \ V+III \ V+IV within 6months.
  4. Renal biopsy reveals active disease.
  5. 24-hour urinary protein was tested twice within two weeks, both of which were greaterthan 1g.
  6. The patients have never received glucocorticoid/immunosuppressants or receivedstandard treatment for more than 1 month without change. The standard treatment shouldfulfill: a. prednisone 0-20mg/day, or equivalent other glucocorticoids; b. acceptableimmunosuppressants, including Tacrolimus ≤ 4mg/d, methotrexate ≤ 15mg/week,azathioprine ≤ 100mg/d and MMF ≤ 1g/d.
  7. Informed consent obtained.

Exclusion

Exclusion Criteria:

  1. Other concomitant connective tissue diseases or autoimmune diseases.
  2. Neuropsychiatric lupus, alveolar hemorrhage, retinal lesions, pulmonary arterialhypertension, or other severe organ involvement.
  3. Pregnant or lactating women.
  4. Current infections that require antibiotic or antiviral treatment.
  5. Other kidney diseases.
  6. Platelet < 50×10^9/L.
  7. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) that is greaterthan 1.5 times the upper limit of the normal value.
  8. Total bilirubin or blood lipid that is greater than 2 times the upper limit of thenormal value.
  9. Other conditions that not suitable for inclusion in the study, assessed by theinvestigators.

Study Design

Total Participants: 100
Study Start date:
December 05, 2023
Estimated Completion Date:
December 05, 2028

Connect with a study center

  • Peking Union Medical College Hospital

    Beijing,
    China

    Active - Recruiting

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