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

NCT06167174 | Recruiting DMC

• 1 other identifier: CSTAR-K2939
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lupus Nephritis

Keywords

Lupus Nephritis

Outcome Measures

Primary Outcomes (1)

• Treatment response of patients

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

  24 weeks

Secondary Outcomes (2)

• Disease progression

  24 weeks

• Adverse events during the study

  24 weeks

Study Arms (2)

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.

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese SLE Treatment And Research Group: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood, kidney tissues and urine

MeSH Terms

Conditions

Lupus Nephritis

Condition Hierarchy (Ancestors)

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

Study Officials

• Xinping Tian, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinping Tian, MD

CONTACT

86-13691165939; tianxp6@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 12, 2023
• Study Start: December 5, 2023
• Primary Completion (Estimated): December 5, 2027
• Study Completion (Estimated): December 5, 2028
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)