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 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT05623033
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 14 years and\<75 years.
2. It meets the diagnostic criteria of primary nephrotic syndrome, i.e. a. A large amount of proteinuria (24h urine protein quantity \> 3.5g/d); b. Hypoalbuminemia (liver function: albumin\<30g/L); c. Edema; d. The blood lipid is elevated. Among them, item a and b are necessary conditions for diagnosis.
3. Nephrocentesis pathology indicates the pathological type of nephrotic syndrome (minimal change glomerulonephritis, membranous nephropathy, focal segmental glomerulonephritis, membranous proliferative glomerulonephritis, mesangial proliferative glomerulonephritis).
4. Glucocorticoids or corticosteroids combined with immunosuppressants should be used clinically.
Exclusion Criteria:
1. Secondary nephrotic syndrome, such as secondary to systemic lupus erythematosus, hepatitis B, hepatitis C, tumor, organic solvent , heavy metal poisoning, etc.
2. Patients with tumor and chronic infectious diseases, such as HIV infection, cardiac insufficiency, acute hepatitis, transaminase increase more than twice the normal value, deep vein thrombosis.
3. The subjects were pregnant and lactating women.
4. Patients with serious primary diseases such as heart, brain, liver and hematopoietic system.
5. Those who can not cooperate, such as the mentally ill.
6. It is known that it is allergic to or has contraindications to any component in glucocorticoid, FK506, MMF and CTX.
7. Serum creatinine (SCR) \> 265.2 μ mol/L（3mg/dl）。
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
75 Years
Study:
NCT05623033
Study Brief:
Protocol Section:
NCT05623033