Predicting infections in nephrotic syndrome patients using CD4+ T lymphocyte changes
The Predictive Value of Dynamic Changes of CD4+T Lymphocytes in Primary Nephrotic Syndrome With Infection
This study is testing if changes in certain immune cells can help predict infections in people with nephrotic syndrome and how different treatments might affect these cells.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 156 (estimated) |
| Ages | 14 Years to 75 Years |
| Sex | All |
| Sponsor | Fifth Affiliated Hospital, Sun Yat-Sen University Academic / other |
| Locations | 1 site (Zhuhai, Guangdong) |
| Trial ID | NCT05623033 on ClinicalTrials.gov |
What this trial studies
This observational study aims to determine if changes in CD4+ T lymphocyte levels can predict infections in patients diagnosed with primary nephrotic syndrome. Participants will be categorized into infection and non-infection groups based on their infection status. The study will also explore how different immunosuppressive therapies affect T lymphocyte subsets in these patients. By analyzing these dynamic changes, the research seeks to enhance understanding of infection risks in this population.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 14 to 75 who have been diagnosed with primary nephrotic syndrome and are undergoing immunosuppressive therapy.
Not a fit: Patients with secondary nephrotic syndrome or those with chronic infectious diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved infection management in patients with primary nephrotic syndrome.
How similar studies have performed: While the approach of using CD4+ T lymphocyte changes to predict infections is innovative, similar studies have not been widely reported, indicating this may be a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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）。
Where this trial is running
Zhuhai, Guangdong
- the fifth affiliated hospital of SUN YAT-SEN university — Zhuhai, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Wei Ping Zhu
- Email: zhuwp@mail.sysu.edu.cn
- Phone: 13926927805
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.