The Predictive Value of Dynamic Changes of CD4+T Lymphocytes in Primary Nephrotic Syndrome With Infection

Fifth Affiliated Hospital, Sun Yat-Sen University

Status: Enrolling

Conditions: Lymphocyte; Infections; Nephrotic Syndrome

Treatments: Other: The study is an observational study without intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05623033

WPZhu

Details and patient eligibility

About

The goal of this observational study is to test whether the dynamic changes of CD4+T lymphocytes can predict infections in patients with primary nephrotic syndrome . The main questions it aims to answer are:

• whether the dynamic changes of CD4+T lymphocytes can predict infections in patients with primary nephrotic syndrome
• effect of different immunosuppressive therapy on the number and function of T lymphocyte subsets in patients with primary nephrotic syndrome

Participants will be divided into infection group and non-infection group according to whether they are infected

Enrollment: 156 estimated patients

Sex: All

Ages: 14 to 75 years old

Volunteers: Accepts Healthy Volunteers

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）。

Trial design

156 participants in 2 patient groups

infection group

Treatment:

Other: The study is an observational study without intervention

non-infection group

Treatment:

Other: The study is an observational study without intervention