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

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

Study Overview

• Status: Recruiting
• Conditions: Infections; Nephrotic Syndrome; Lymphocyte
• Intervention / Treatment: Other: The study is an observational study without intervention

• Study Type: Observational
• Enrollment (Anticipated): 156

Contacts and Locations

• Study Contact: Name: Wei Ping Zhu; Phone Number: 0756-2528701 13926927805; Email: zhuwp@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Zhuhai, Guangdong, China, 519000
      • Recruiting
      • The Fifth Affiliated Hospital of Sun Yat-sen University
      • Contact: ZHU weiping, associate chief physician; Phone Number: 13926927805 13926927805; Email: 292428893@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with primary nephrotic syndrome

Description

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）。

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
infection group	Other: The study is an observational study without intervention; The study is an observational study without intervention
non-infection group	Other: The study is an observational study without intervention; The study is an observational study without intervention

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University
• Collaborators: Nanfang Hospital of Southern Medical University; Guangdong traditional Chinese medicine hospital, Zhuhai

Study record dates

Study Major Dates

• Study Start (Anticipated): November 16, 2022
• Primary Completion (Anticipated): August 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 17, 2022
• First Posted (Actual): November 21, 2022

Study Record Updates

• Last Update Posted (Actual): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 20, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Disease; Syndrome; Infections; Communicable Diseases; Nephrotic Syndrome; Nephrosis
• Other Study ID Numbers: WPZhu

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No