NephropathyNCT06456801
Clinical Trial of Anti-PLA2R-IgG Detection Kit (Time-resolved Fluorescence Immunoassay)
An observational study of Nephropathy, run by Zhejiang University at 1 site in China.
Trial summary
Conduct comparative experimental studies on clinical serum samples using assessment reagents and approved products, and evaluate the equivalence between assessment reagents and comparison reagents. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nephropathy
- How many people
- 219 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 1 Oct 2021
- 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: Chronic kidney disease
Who may be able to join
- Clear background information and traceable sources of samples from kidney disease patients (number, age, gender, and clinical diagnostic information).
Who cannot join
- Exclude serum samples that meet one of the following conditions:
- ① Samples with insufficient sample size, ② Samples with incomplete sample information.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated hospital Zhejiang University school of medicine
Hangzhou, Zhejiang, 310001
About this study
Conduct comparative experimental studies on clinical serum samples using assessment reagents and approved products, and evaluate the equivalence between assessment reagents and comparison reagents.
Read the detailed description
Conduct comparative experimental studies on clinical serum samples using assessment reagents and approved products, and evaluate the equivalence between assessment reagents and comparison reagents.
- Conditions
- Nephropathy
- Medical subject headings
- Kidney Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculate the correlation between the test reagents and comparison reagents
Calculate the correlation between the test reagents and comparison reagents
Measured: 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Mar 2021
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephropathyStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Du Xiaoying, Zhejiang University
- Investigators
- Xiaoying Du, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456801
- Sponsor's protocol ID
- zjbs-pla2r-2012
- Status last verified
- Jun 2024
- First submitted
- 7 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Anti-PLA2R-IgG Detection Kit (Time-resolved Fluorescence Immunoassay)
- ClinicalTrials.gov ID
- NCT06456801
- Acronym / sponsor ID
- zjbs-pla2r-2012
- Conditions
- Nephropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 13 Jun 2024 (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.
Conduct comparative experimental studies on clinical serum samples using assessment reagents and approved products, and evaluate the equivalence between assessment reagents and comparison reagents.
Detailed description
Conduct comparative experimental studies on clinical serum samples using assessment reagents and approved products, and evaluate the equivalence between assessment reagents and comparison reagents.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chronic kidney disease
Key inclusion criteria (1 listed)
- Clear background information and traceable sources of samples from kidney disease patients (number, age, gender, and clinical diagnostic information).
Key exclusion criteria (2 listed)
- ① Samples with insufficient sample size, ② Samples with incomplete sample 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
Calculate the correlation between the test reagents and comparison reagents
Time frame: 1 year.
Calculate the correlation between the test reagents and comparison reagents
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
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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.
Xiaoying Du principal investigator
Zhejiang University
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 Nephropathy, run by Zhejiang 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 13 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Calculate the correlation between the test reagents and comparison reagents (time frame: 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 13 Jun 2024.