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

NCT05623033 | Unknown

• 1 other identifier: WPZhu
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

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

Conditions

Nephrotic Syndrome; Infections; Lymphocyte

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

infection group

Other: The study is an observational study without intervention

non-infection group

Other: The study is an observational study without intervention

Interventions

The study is an observational study without intervention OTHER

The study is an observational study without intervention

infection group; non-infection group

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with primary nephrotic syndrome

You may qualify if:

• Age ≥ 14 years and\<75 years.
• 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.
• Nephrocentesis pathology indicates the pathological type of nephrotic syndrome (minimal change glomerulonephritis, membranous nephropathy, focal segmental glomerulonephritis, membranous proliferative glomerulonephritis, mesangial proliferative glomerulonephritis).
• Glucocorticoids or corticosteroids combined with immunosuppressants should be used clinically.

You may not qualify if:

• Secondary nephrotic syndrome, such as secondary to systemic lupus erythematosus, hepatitis B, hepatitis C, tumor, organic solvent , heavy metal poisoning, etc.
• 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.
• The subjects were pregnant and lactating women.
• Patients with serious primary diseases such as heart, brain, liver and hematopoietic system.
• Those who can not cooperate, such as the mentally ill.
• It is known that it is allergic to or has contraindications to any component in glucocorticoid, FK506, MMF and CTX.
• Serum creatinine (SCR) \> 265.2 μ mol/L（3mg/dl）。

Sponsors & Collaborators

• Fifth Affiliated Hospital, Sun Yat-Sen University: lead
• Nanfang Hospital, Southern Medical University: collaborator
• Guangdong traditional Chinese medicine hospital, Zhuhai: collaborator

Study Sites (1)

the fifth affiliated hospital of SUN YAT-SEN university

Zhuhai, Guangdong, 519000, China

RECRUITING

MeSH Terms

Conditions

Nephrotic Syndrome; Infections

Interventions

Methods

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Wei Ping Zhu

CONTACT

13926927805; zhuwp@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 21, 2022
• Study Start: November 16, 2022
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 22, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)