Clinical Trial of PLA2R-IgG4 Detection Kit (Time-resolved Fluorescence Immunoassay)
China450 participantsStarted 2023-05-04
Plain-language 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.
* 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.
Who can participate
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Content of anti-PLA2r IgG4
Timeframe: through study completion, an average of 1 year