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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05623033

Enrollment

156

Registered

2022-11-21

Start date

2022-11-16

Completion date

2025-12-31

Last updated

2022-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections, Lymphocyte, Nephrotic Syndrome

Brief summary

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

Interventions

OTHERThe study is an observational study without intervention

The study is an observational study without intervention

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

14 Years to 75 Years

Healthy volunteers

Yes

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）。

Design outcomes

Primary

Measure	Time frame	Description
Dynamic changes of CD4+T cells	3 years after the project starts	Whether the change of CD4+T lymphocytes count can predict infections in patients with primary nephrotic syndrome

Countries

China

Contacts

Primary ContactWei Ping Zhu

zhuwp@mail.sysu.edu.cn13926927805

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026