NCT06167174 Exploring Biomarkers for Therapeutic Response of Lupus Nephritis Based on Multi Omics Analysis
| NCT ID | NCT06167174 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese SLE Treatment And Research Group |
| Condition | Lupus Nephritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-12-05 |
| Primary Completion | 2027-12-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2023-12-05 with a primary completion date of 2027-12-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Xinping Tian, MD
PRINCIPAL INVESTIGATOR
Peking Union Medical College Hospital
Frequently Asked Questions
Who can join the NCT06167174 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 60 Years, studying Lupus Nephritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06167174 currently recruiting?
Yes, NCT06167174 is actively recruiting participants. Contact the research team at tianxp6@126.com for enrollment information.
Where is the NCT06167174 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06167174 clinical trial?
NCT06167174 is sponsored by Chinese SLE Treatment And Research Group. The principal investigator is Xinping Tian, MD at Peking Union Medical College Hospital. The trial plans to enroll 100 participants.
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