The Predictive Value of Dynamic Changes of CD4+T Lymphocy... | NCT05623033

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

NCT05623033

Sponsor

Fifth Affiliated Hospital, Sun Yat-Sen University

Status

Unknown status

Last Update Posted

Nov 22, 2022Actual

Enrollment

156Estimated

Phase

Not provided

Conditions

Nephrotic Syndrome
Infections
Lymphocyte

Interventions

The study is an observational study without intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 16, 2022Estimated

Primary Completion Date

Aug 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Nov 7, 2022

First Submission Date that Met QC Criteria

Nov 17, 2022

First Posted Date

Nov 21, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2022

Last Update Posted Date

Nov 22, 2022Actual

Name	Class
Nanfang Hospital, Southern Medical University	OTHER
Guangdong traditional Chinese medicine hospital, Zhuhai	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

156Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
infection group			Other: The study is an observational study without intervention
non-infection group			Other: The study is an observational study without intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
The study is an observational study without intervention	Other	The study is an observational study without intervention	infection group non-infection group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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）。

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

patients with primary nephrotic syndrome

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Wei Ping Zhu	Contact	13926927805	0756-2528701	zhuwp@mail.sysu.edu.cn

Facility	Status	City	State	ZIP	Country	Contacts
the fifth affiliated hospital of SUN YAT-SEN university	Recruiting	Zhuhai	Guangdong	519000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D009401	Nephrosis
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

ID	Term
D009404	Nephrotic Syndrome
D007239	Infections