NCT06167174Recruiting
Exploring Biomarkers for Therapeutic Response of Lupus Nephritis Based on Multi Omics Analysis
Exploring Biomarkers for Therapeutic Response of Lupus Nephritis Based on Multi Omics
Source: ClinicalTrials.gov · Last updated 12 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 4 Dec 2023
- Start date
- 5 Dec 2023
- Primary completion date
- 5 Dec 2027
- Lead sponsor
- Chinese SLE Treatment And Research Group
- Diseases
- Lupus (SLE)
- NCT number
- NCT06167174
What you commit to
- Study type: Observational
- Planned participants: 100
- From 5 Dec 2023 to the primary completion date, 5 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other concomitant connective tissue diseases or autoimmune diseases.
Other illness
- Neuropsychiatric lupus, alveolar hemorrhage, retinal lesions, pulmonary arterial hypertension, or other severe organ involvement.
- Current infections that require antibiotic or antiviral treatment.
- Other kidney diseases.
- Other conditions that not suitable for inclusion in the study, assessed by the investigators.
Lab values
- 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
- Pregnant or lactating women.
Who the study is looking for
- 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.
Age in the registry: 16 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.