Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT03791827
Eligibility Criteria:
Inclusion Criteria:
Diagnosis of lupus nephritis:
* Diagnosis of SLE according to the 1997 update of the 1982 American College of Rheumatology revised criteria for classification of systemic lupus erythematosus
* Either of the following: Positive urine protein detected 3 times within a week, or 24-hour urine protein\>150mg, or UPC\>0.2mg/mg, or urinary microalbumin above normal range detected 3 times within a week, or microscopic examination erythrocyte\>5 RBC/HP, or renal dysfunction including glomerular and/or tubular dyfunction, or abnormal renal biopsy and the pathological changes are in accordance with lupus nephritis
* The pathological diagnosis of kidney conforms to the International Society of Nephrology and Society of Renal Pathology (ISN/RPS) standards in 2003
Exclusion Criteria (either of the following criteria):
* Complicated with other systemic diseases, including basic diseases with clinical significance
* Patients with tumors
* Patients with abnormal glucose metabolism
* Immunodeficiency patients
* Patients diagnosed as tuberculosis, or hepatitis B, or hepatitis C within three months before treatment
* Patients with other connective tissue diseases (such as Sjogren's syndrome, mixed connective tissue disease, etc.)
* Drug-induced lupus, congenital lupus and other secondary lupus
* Renal histopathology with non-inflammatory necrotizing angiopathy or thrombotic microangiopathy (TMA)
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT03791827
Study Brief:
Protocol Section:
NCT03791827