Characteristics of Peripheral Blood Lymphocyte Subsets in Children With PNS
The Profiles of Peripheral Blood Lymphocyte Subsets and Risk Factor of Infection in Children With Primary Nephrotic Syndrome
1 other identifier
observational
100
0 countries
N/A
Brief Summary
The etiology and precipitating factors of PNS remain unclear. Dysfunction of immunologic function is a classic theory of the pathogenesis of PNS. This study was aimed at investigating the characteristics of peripheral blood lymphocyte subsets and exploring its value of predicting infection in children with primary nephrotic syndrome (PNS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2022
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2022
CompletedFirst Posted
Study publicly available on registry
May 26, 2022
CompletedStudy Start
First participant enrolled
May 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2022
CompletedMay 26, 2022
May 1, 2022
1 month
May 22, 2022
May 22, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
peripheral blood lymphocyte subsets
The percentage and absolute counts of lymphocyte subsets were conducted with a BD Canto Ⅱ flow cytometry (FCM)
2019.9-2020.12
biochemical indicators
biochemical indicators which were related to PNS, including 24-hour urine protein (UTP), serum albumin (ALB), serum total cholesterol (CHOL) and serum creatinine (Scr) were collected
2019.9-2020.12
Study Arms (3)
active group
Active PNS was defined as a serum albumin concentration of \<2.5 g/dL and a urinary protein excretion of \>40 mg/m2 per hour with high cholesterol levels.
partial remission group
Partial remission PNS was defined as symptoms between active group and complete remission group.
complete remission group
PNS in remission was defined as no proteinuria using the colorimetric qualitative test and a urinary protein/creatinine ratio of \<0.2 on a random urine sample.
Eligibility Criteria
From September, 2019 to April, 2021, a total of 89 children who were admitted in the Nanfang Hospital Affiliated to Southern Medical University and met the Evidence-based Guidelines for the Diagnosis and Treatment of Children's Hormone Sensitivity, Relapsed/Dependent Nephrotic Syndrome (2016), were enrolled in this study.
You may qualify if:
- age \<18 years old
- first PNS episode or PNS in remission
- no history of corticosteroid or immunosuppressor use in the four weeks prior to disease occurrence
You may not qualify if:
- Subjects with infantile (or congenital) nephrotic syndrome (NS), secondary NS, glomerulonephritis, or systemic disease were excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2022
First Posted
May 26, 2022
Study Start
May 30, 2022
Primary Completion
June 30, 2022
Study Completion
August 31, 2022
Last Updated
May 26, 2022
Record last verified: 2022-05