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

Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05623033
• Other study ID #: WPZhu
• Status: Recruiting
• Start date: November 16, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2022
• Source: Fifth Affiliated Hospital, Sun Yat-Sen University
• Contact: Wei Ping Zhu
• Phone: 13926927805
• Email: zhuwp[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: December 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 75 Years

Eligibility

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)?

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Nephrosis
• Nephrotic Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
China	the fifth affiliated hospital of SUN YAT-SEN university	Zhuhai	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Fifth Affiliated Hospital, Sun Yat-Sen University	Guangdong traditional Chinese medicine hospital, Zhuhai, Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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