Nephrotic SyndromeNCT05623033
The Predictive Value of Dynamic Changes of CD4+T Lymphocytes in Primary Nephrotic Syndrome With Infection
An observational study of Nephrotic Syndrome and Infections, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 14 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Nephrotic Syndrome, Infections, Lymphocyte
- What is being tested?
- The study is an observational study without intervention
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 16 Nov 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients with primary nephrotic syndrome
Who may be able to join
- 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.
Who cannot join
- 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）。
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the fifth affiliated hospital of SUN YAT-SEN university
Zhuhai, Guangdong, 519000
ZHU weiping, associate chief physician, 13926927805 ext. 13926927805, 292428893@qq.com
About this study
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
- Being tested
- The study is an observational study without intervention
- Medical subject headings
- Nephrotic Syndrome, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The study is an observational study without interventionOther
The study is an observational study without intervention
| Study group | Role | What they receive |
|---|---|---|
| infection group | Not described Receives: Other: The study is an observational study without intervention | |
| non-infection group | Not described Receives: Other: The study is an observational study without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic changes of CD4+T cells
Whether the change of CD4+T lymphocytes count can predict infections in patients with primary nephrotic syndrome
Measured: 3 years after the project starts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start16 Nov 2022 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrotic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, Guangdong traditional Chinese medicine hospital, Zhuhai
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623033
- Sponsor's protocol ID
- WPZhu
- Status last verified
- Nov 2022
- First submitted
- 7 Nov 2022
- Last updated
- 22 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of Dynamic Changes of CD4+T Lymphocytes in Primary Nephrotic Syndrome With Infection
- ClinicalTrials.gov ID
- NCT05623033
- Acronym / sponsor ID
- WPZhu
- Conditions
- Nephrotic Syndrome, Infections, Lymphocyte
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, Guangdong traditional Chinese medicine hospital, Zhuhai
- Study start
- 16 Nov 2022 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| infection group | – | Other: The study is an observational study without intervention |
| non-infection group | – | Other: The study is an observational study without intervention |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with primary nephrotic syndrome
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The study is an observational study without interventionThe study is an observational study without intervention | Other | infection group, non-infection group |
Primary outcome
Dynamic changes of CD4+T cells
Time frame: 3 years after the project starts
Whether the change of CD4+T lymphocytes count can predict infections in patients with primary nephrotic syndrome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nephrotic Syndrome and Infections, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Ping Zhu (13926927805 ext. 0756-2528701, zhuwp@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic changes of CD4+T cells (time frame: 3 years after the project starts). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2022.