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

NCT ID: NCT05623033

Last Updated: 2022-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

156 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-16

Study Completion Date

2025-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Nephrotic Syndrome Infections Lymphocyte

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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infection group

The study is an observational study without intervention

Intervention Type OTHER

The study is an observational study without intervention

non-infection group

The study is an observational study without intervention

Intervention Type OTHER

The study is an observational study without intervention

Interventions

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The study is an observational study without intervention

The study is an observational study without intervention

Intervention Type OTHER

Eligibility Criteria

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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)。
Minimum Eligible Age

14 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role collaborator

Guangdong traditional Chinese medicine hospital, Zhuhai

UNKNOWN

Sponsor Role collaborator

Fifth Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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the fifth affiliated hospital of SUN YAT-SEN university

Zhuhai, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei Ping Zhu

Role: CONTACT

13926927805 ext. 0756-2528701

Facility Contacts

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ZHU weiping, associate chief physician

Role: primary

13926927805 ext. 13926927805

Other Identifiers

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WPZhu

Identifier Type: -

Identifier Source: org_study_id

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