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NCT Number: NCT06167174

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

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.

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Key information

Conditions

Lupus Nephritis Autoimmune Diseases Connective Tissue Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Immune System Diseases Kidney Diseases Lupus Erythematosus, Systemic Male Urogenital Diseases Nephritis Skin and Connective Tissue Diseases Urogenital Diseases Urologic Diseases

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Other kidney diseases.
  • Platelet < 50×10^9/L.
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) that is greater than 1.5 times the upper limit of the normal value.
  • Total bilirubin or blood lipid that is greater than 2 times the upper limit of the normal value.
  • Other conditions that not suitable for inclusion in the study, assessed by the investigators.

Treatment and study plan

Primary outcomes

  1. Treatment response of patients

    Time frame: 24 weeks

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

Secondary outcomes

  1. Disease progression

    Time frame: 24 weeks

    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.

  2. Adverse events during the study

    Time frame: 24 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Xinping Tian, MD

CONTACT

[email protected]

86-13691165939

Sponsors and collaborators

Lead sponsor

Chinese SLE Treatment And Research Group

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Dec 12, 2023
Registry last updated
Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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