Primary Membranous NephropathyNCT06924476
Optimization of a Decision Formula for Optimal Timing of Immunosuppressive Therapy Initiation in Primary Membranous Nephropathy: A Multicenter Retrospective Cohort Study
An observational study of Primary Membranous Nephropathy, run by Yipeng Liu at 1 site in China.
Trial summary
The goal of this observational study is to optimize the evaluation formula for the timing of initiating immunosuppressive therapy in primary membranous nephropathy in patients with primary membranous nephropathy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Membranous Nephropathy
- How many people
- 282 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 1990to 30 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients who were registered in the Renal Disease Syndrome Multi-center Cohort Network (https://nsn.bjmu.edu.cn/index) and whose medical records were complete, and who met the PMN diagnostic criteria as stipulated in the KDIGO 2021 Clinical Practice Guidelines for the Management of Glomerular Diseases.
Who may be able to join
- It meets one of the diagnostic criteria for PMN as stipulated in the KDIGO 2021 Clinical Practice Guidelines for the Management of Glomerular Diseases: patients with a clear diagnosis of PMN based on renal biopsy pathology or presenting with nephrotic syndrome and positive anti-PLA2R antibody detection (>14RU/mL), and excluding secondary factors such as tumors, infections, drugs, and systemic autoimmune diseases.
Who cannot join
- (1) Patients who have received treatment with immunosuppressive medications other than oral prednisolone.
- The time interval between the renal biopsy and the baseline measurement is longer than 3 years.
- Initiate the use of immunosuppressive agents within 1 week after the diagnosis of PMN.
- Participate in the immunosuppressive treatment trial during the follow-up period and be in the intervention group.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to optimize the evaluation formula for the timing of initiating immunosuppressive therapy in primary membranous nephropathy in patients with primary membranous nephropathy. The main question it aims to answer is:When should immunosuppressive therapy be initiated?This study is a retrospective one. Participants will not receive any treatment.
- Conditions
- Primary Membranous Nephropathy
- Keywords
- Primary Membranous Nephropathy, Evaluation formula, Initiate immunosuppressive therapy
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 |
|---|---|---|
| Modeling Group | The data of this group of participants are used to construct the evaluation formula. | |
| Verification group | The data of this group of participants are used to verify the evaluation formula constructed through the modeling group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reasonably add immunosuppressive therapy
Reasonably add immunosuppressive therapy, that is, refer to the risk stratification of PMN in the "KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases". Immunosuppressive therapy can be initiated for patients with moderate or higher risk; or for those whom the treating doctor deems to require immunosuppressive therapy due to severe and incurable nephrotic syndrome and its serious complications. Meeting either of the two conditions is sufficient.
Measured: From enrollment to the reasonable addition of immunosuppressive agent treatme，no less than one weeknt
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start1 Jan 1990
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Membranous NephropathyStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 282 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yipeng Liu
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital
- Responsible party
- Sponsor-investigator, Yipeng Liu, Qianfoshan Hospital
- Investigators
- Yipeng Liu, Study chair, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924476
- Sponsor's protocol ID
- YXLL-KY-2025(064)
- Status last verified
- Mar 2025
- First submitted
- 6 Apr 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- 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 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of a Decision Formula for Optimal Timing of Immunosuppressive Therapy Initiation in Primary Membranous Nephropathy: A Multicenter Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06924476
- Acronym / sponsor ID
- YXLL-KY-2025(064)
- Conditions
- Primary Membranous Nephropathy
- Keywords
- Primary Membranous Nephropathy, Evaluation formula, Initiate immunosuppressive therapy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 282 participants (estimated)
- Lead sponsor
- Yipeng LiuUniversity, hospital or other
- Collaborators
- Peking University First Hospital
- Study start
- 1 Jan 1990 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 11 Apr 2025 (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 optimize the evaluation formula for the timing of initiating immunosuppressive therapy in primary membranous nephropathy in patients with primary membranous nephropathy. The main question it aims to answer is:When should immunosuppressive therapy be initiated?This study is a retrospective one. Participants will not receive any treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modeling Group | – | –The data of this group of participants are used to construct the evaluation formula. |
| Verification group | – | –The data of this group of participants are used to verify the evaluation formula constructed through the modeling group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who were registered in the Renal Disease Syndrome Multi-center Cohort Network (https://nsn.bjmu.edu.cn/index) and whose medical records were complete, and who met the PMN diagnostic criteria as stipulated in the KDIGO 2021 Clinical Practice Guidelines for the Management of Glomerular Diseases.
Key inclusion criteria (1 listed)
- It meets one of the diagnostic criteria for PMN as stipulated in the KDIGO 2021 Clinical Practice Guidelines for the Management of Glomerular Diseases: patients with a clear diagnosis of PMN based on renal biopsy pathology or presenting with nephrotic syndrome and positive anti-PLA2R antibody detection (>14RU/mL), and excluding secondary factors such as tumors, infections, drugs, and systemic autoimmune diseases.
Key exclusion criteria (4 listed)
- (1) Patients who have received treatment with immunosuppressive medications other than oral prednisolone.
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
Reasonably add immunosuppressive therapy
Time frame: From enrollment to the reasonable addition of immunosuppressive agent treatme，no less than one weeknt
Reasonably add immunosuppressive therapy, that is, refer to the risk stratification of PMN in the "KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases". Immunosuppressive therapy can be initiated for patients with moderate or higher risk; or for those whom the treating doctor deems to require immunosuppressive therapy due to severe and incurable nephrotic syndrome and its serious complications. Meeting either of the two conditions is sufficient.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- 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.
Yipeng Liu study chair
Qianfoshan Hospital
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 Primary Membranous Nephropathy, run by Yipeng Liu 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 4 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: under way, not looking for participants, as of the sponsor's last update on 11 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Reasonably add immunosuppressive therapy (time frame: From enrollment to the reasonable addition of immunosuppressive agent treatme，no less than one weeknt). 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 11 Apr 2025.