Membranous Nephropathy - PLA2R InducedNCT05861869
Clinical Trial of PLA2R-IgG4 Detection Kit (Time-resolved Fluorescence Immunoassay)
An observational study of Membranous Nephropathy - PLA2R Induced and Kidney Diseases-except Membranous Nephropathy, run by Zhejiang Biostar Biotechnology Co. at 1 site in China.
Trial summary
The goal of this observational clinical trial is to compare assessment reagents with clinical diagnostic criteria in patients with membranous nephropathy. The main questions it aims to answer are: Evaluating the sensitivity and specificity of the test reagent in the diagnosis of membranous nephropathy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Membranous Nephropathy - PLA2R Induced, Kidney Diseases-except Membranous Nephropathy
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 4 May 2023to Jun 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Nephrology department visit /inpatient case
Who may be able to join
- PLA2R-induced membranous nephropathy group
- Pathological examination showed that patients with membranous nephropathy were positive for PLA2R by immunohistochemistry, and the symptoms were not completely relieved; (24 h urine protein quantification<0.3g or urine protein /creatinine (uPCR)<300mg /g is regarded as complete remission)
- In patients with nephrotic syndrome (serum albumin ≤ 30.0g /L, clinical manifestations show moderate to large amount of proteinuria (urine protein>3.5g /L or urine protein /creatinine ratio ≥ 3500mg /g), and their serum anti PLA2R antibody detection shows positive.
- Secondary membranous nephropathy group Patients in nephrology department who have ruled out primary membranous nephropathy.
- the patient has the remaining serum samples of normal test, and the serum volume of the sample is not less than 1ml.
Who cannot join
- The amount of centrifuged serum sample after blood collection is less than 1ml or the amount of residual serum in normal test is less than 1ml;
- Non-serum samples, plasma samples;
- Patients with mental or cognitive disorders;
- No samples with definite clinical diagnosis;
- Samples with incomplete information.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational clinical trial is to compare assessment reagents with clinical diagnostic criteria in patients with membranous nephropathy. The main questions it aims to answer are:
- Evaluating the sensitivity and specificity of the test reagent in the diagnosis of membranous nephropathy.
- Evaluating whether the clinical diagnostic performance of the test reagent meets the requirements for auxiliary diagnosis of membranous nephropathy.
Participants will provide approximately 4ml of blood. Researchers will compare the levels of anti-PLA2RIgG4 in patients with membranous nephropathy and patients with other renal diseases,to see if there is a significant difference.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PLA2R-induced membranous nephropathy group | 1. Pathological examination showed that patients with membranous nephropathy were positive for PLA2R by immunohistochemistry, and the symptoms were not completely relieved; (24 h urine protein quantification<0.3g or urine protein /creatinine (uPCR)<300mg /g is regarded as complete remission) 2. In patients with nephrotic syndrome (serum albumin ≤ 30.0g /L, clinical manifestations show moderate to large amount of proteinuria (urine protein>3.5g /L or urine protein /creatinine ratio ≥ 3500mg /g), and their serum anti PLA2R antibody detection shows positive. | |
| Secondary membranous nephropathy group | 1. Patients in nephrology department who have ruled out primary membranous nephropathy. 2. the patient has the remaining serum samples of normal test, and the serum volume of the sample is not less than 1ml. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Content of anti-PLA2r IgG4
Evaluating the sensitivity and specificity of the test reagent in the diagnosis of membranous nephropathy
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start4 May 2023
- Primary completionFeb 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Membranous Nephropathy - PLA2R InducedStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Biostar Biotechnology Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- First Affiliated Hospital of Zhejiang University, Wuxi People's Hospital, Guangdong Provincial People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861869
- Sponsor's protocol ID
- ZJBS-PLA2R IgG4-2201
- Status last verified
- May 2023
- First submitted
- 10 Apr 2023
- Last updated
- 21 Feb 2024
- 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 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of PLA2R-IgG4 Detection Kit (Time-resolved Fluorescence Immunoassay)
- ClinicalTrials.gov ID
- NCT05861869
- Acronym / sponsor ID
- ZJBS-PLA2R IgG4-2201
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Zhejiang Biostar Biotechnology Co.Industry (pharma, biotech, devices)
- Collaborators
- First Affiliated Hospital of Zhejiang University, Wuxi People's Hospital, Guangdong Provincial People's Hospital
- Study start
- 4 May 2023 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 17 May 2023 (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 clinical trial is to compare assessment reagents with clinical diagnostic criteria in patients with membranous nephropathy. The main questions it aims to answer are:
- Evaluating the sensitivity and specificity of the test reagent in the diagnosis of membranous nephropathy.
- Evaluating whether the clinical diagnostic performance of the test reagent meets the requirements for auxiliary diagnosis of membranous nephropathy.
Participants will provide approximately 4ml of blood. Researchers will compare the levels of anti-PLA2RIgG4 in patients with membranous nephropathy and patients with other renal diseases,to see if there is a significant difference.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLA2R-induced membranous nephropathy group | – | –1. Pathological examination showed that patients with membranous nephropathy were positive for PLA2R by immunohistochemistry, and the symptoms were not completely relieved; (24 h urine protein quantification<0.3g or urine protein /creatinine (uPCR)<300mg /g is regarded as complete remission) 2. In patients with nephrotic syndrome (serum albumin ≤ 30.0g /L, clinical manifestations show moderate to large amount of proteinuria (urine protein>3.5g /L or urine protein /creatinine ratio ≥ 3500mg /g), and their serum anti PLA2R antibody detection shows positive. |
| Secondary membranous nephropathy group | – | –1. Patients in nephrology department who have ruled out primary membranous nephropathy. 2. the patient has the remaining serum samples of normal test, and the serum volume of the sample is not less than 1ml. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Nephrology department visit /inpatient case
Key inclusion criteria (5 listed)
- PLA2R-induced membranous nephropathy group
- Secondary membranous nephropathy group Patients in nephrology department who have ruled out primary membranous nephropathy.
- the patient has the remaining serum samples of normal test, and the serum volume of the sample is not less than 1ml.
Key exclusion criteria (5 listed)
- The amount of centrifuged serum sample after blood collection is less than 1ml or the amount of residual serum in normal test is less than 1ml;
- Non-serum samples, plasma samples;
- Patients with mental or cognitive disorders;
- No samples with definite clinical diagnosis;
- Samples with incomplete information.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Content of anti-PLA2r IgG4
Time frame: through study completion, an average of 1 year
Evaluating the sensitivity and specificity of the test reagent in the diagnosis of membranous nephropathy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Membranous Nephropathy - PLA2R Induced and Kidney Diseases-except Membranous Nephropathy, run by Zhejiang Biostar Biotechnology Co. 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 5 inclusion and 5 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 21 Feb 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Content of anti-PLA2r IgG4 (time frame: through study completion, an average of 1 year). 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 21 Feb 2024.