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

Lupus Nephritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06167174
• Other study ID #: CSTAR-K2939
• Status: Recruiting
• Start date: December 5, 2023
• Est. completion date: December 5, 2028

Study information

• Verified date: December 2023
• Source: Chinese SLE Treatment And Research Group
• Contact: Xinping Tian, MD
• Phone: 86-13691165939
• Email: tianxp6[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 5, 2028
• Est. primary completion date: December 5, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

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 6 months.

4. Renal biopsy reveals active disease.

5. 24-hour urinary protein was tested twice within two weeks, both of which were greater than 1g.

6. 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.

7. Informed consent obtained.

Exclusion Criteria:

1. Other concomitant connective tissue diseases or autoimmune diseases.

2. Neuropsychiatric lupus, alveolar hemorrhage, retinal lesions, pulmonary arterial hypertension, 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 greater than 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 the normal value.

9. Other conditions that not suitable for inclusion in the study, assessed by the investigators.

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese SLE Treatment And Research Group

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment response of patients	The proportion of patients who achieve complete response, partial response or no response 24 weeks after baseline	24 weeks
Secondary	Disease progression	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.	24 weeks
Secondary	Adverse events during the study	All adverse events, severe adverse events and proportion of patients who discontinued the treatment due to adverse events within the duration of the study.	24 weeks