Primary Membranous NephropathyPMNTRWSNCT06893328
A Real World Study About PMN
An observational study of Primary Membranous Nephropathy, run by Wei Chen at 1 site in China.
Trial summary
The investigators designed a randomized, controlled, multicenter clinical study to compare the efficacy and safety of rituximab combined with hormones versus rituximab monotherapy in the treatment of primary membranous nephropathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Membranous Nephropathy
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2024to 11 Nov 2027
- How long will I take part?
- 2 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed as primary membranous nephropathy (PMN) by renal biopsy, with indications for immunosuppressive therapy.
Who may be able to join
- 1. Diagnosed as primary membranous nephropathy (PMN) by renal biopsy; 2. Aged over 18 years; 3. An average 24-hour urine protein ≥ 3.5g twice a week after treatment with ACE inhibitors or ARBs for at least 3 months.
- -
Who cannot join
- With secondary membranous nephropathy (such as hepatitis B and C, systemic lupus erythematosus, drug therapy, malignant tumors and other secondary causes);
- Active infection, such as active hepatitis B or hepatitis C, tuberculosis (evidence of active tuberculosis infection within 1 year), or human immunodeficiency virus HIV infection (positive for anti-HIV antibodies), etc.
- A history of immunodeficiency, including other acquired or congenital immunodeficiency diseases, or organ transplantation.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Wei Chen
Guangzhou, Guangdong, 510080
Qiong Wen, 8602087769673, wenqiong@mail.sysu.edu.cn
About this study
Official title: PMNTRWS: A Non-interventional Study on Treatment and Therapeutic Efficacy in Chinese Patients With Primary Membranous Nephropathy (PMNTRWS)"
The investigators designed a randomized, controlled, multicenter clinical study to compare the efficacy and safety of rituximab combined with hormones versus rituximab monotherapy in the treatment of primary membranous nephropathy. At the same time, the investigators conducted a real-world study on patients who did not meet the inclusion and exclusion criteria or were unwilling to enter the RCT cohort, to further observe the trial results in a broader population.
Read the detailed description
Outcomes
- Primary objective Treatment of primary membranous nephropathy with conventional clinical protocols and observation of its effectiveness and safety in a wide population.
- Exploratory purpose
- Evaluate the genome-wide changes in kidney and peripheral blood during treatment.
- To evaluate the changes in the single-cell transcriptome of the kidney and peripheral blood during treatment.
- Evaluate the changes in the RNA transcriptome of the kidney and peripheral blood during treatment.
- Evaluate the changes in the renal and peripheral blood proteome during treatment.
- Assess the changes in the metabolome during treatment.
- Assess changes in the microbiome during treatment.
- Predict the effective population of rituximab by baseline renal pathological images.
- Primary outcome The complete response rate at 12 months;
- Secondary outcomes
- Response rates at 6, 12, 18 and 24 months (including the proportion of participants with complete response and partial response);
- Median remission time;
- Proportion of patients without recurrence at 12, 18 and 24 months;
- Median non-recurrence time;
- Cumulative dose of glucocorticoids;
- CD19+ cell count, anti-PLA2R antibody expression level;
- Renal function index: eGFR;
- Incidence of adverse events;
- Conditions
- Primary Membranous Nephropathy
- Keywords
- Real-world Study
What is being measured
The primary outcome is the main question the study is designed to answer.
The complete response rate at 12 months
The complete response rate at 12 months
Measured: 12 months
Secondary outcomes (8)
Response rates at 6, 12, 18 and 24 months (including the proportion of participants with complete response and partial response)
Response rates at 6, 12, 18 and 24 months (including the proportion of participants with complete response and partial response)
Measured: 24 months
Median remission time
Median remission time
Measured: 24 months
Proportion of patients without recurrence at 12, 18 and 24 months
Proportion of patients without recurrence at 12, 18 and 24 months
Measured: 24 months
Median non-recurrence time
Median non-recurrence time
Measured: 24 months
Cumulative dose of glucocorticoids
Cumulative dose of glucocorticoids
Measured: 24 months
CD19+ cell count, anti-PLA2R antibody expression level
CD19+ cell count, anti-PLA2R antibody expression level
Measured: 24 months
Renal function index: eGFR
Renal function index: eGFR
Measured: 24 months
Incidence of adverse events
Incidence of adverse events
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start11 Nov 2024
- Primary completion11 Nov 2027 (estimated)
- Study completion11 Nov 2027 (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
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Wei Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei Chen, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893328
- Sponsor's protocol ID
- CR2023588-1
- Acronym
- PMNTRWS
- Status last verified
- Aug 2025
- First submitted
- 19 Mar 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PMNTRWS: A Non-interventional Study on Treatment and Therapeutic Efficacy in Chinese Patients With Primary Membranous Nephropathy (PMNTRWS)"
- ClinicalTrials.gov ID
- NCT06893328
- Acronym / sponsor ID
- PMNTRWS / CR2023588-1
- Conditions
- Primary Membranous Nephropathy
- Keywords
- Real-world Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Wei ChenUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 11 Nov 2027 (estimated)
- Study completion
- 11 Nov 2027 (estimated)
- First posted
- 25 Mar 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 investigators designed a randomized, controlled, multicenter clinical study to compare the efficacy and safety of rituximab combined with hormones versus rituximab monotherapy in the treatment of primary membranous nephropathy. At the same time, the investigators conducted a real-world study on patients who did not meet the inclusion and exclusion criteria or were unwilling to enter the RCT cohort, to further observe the trial results in a broader population.
Detailed description
Outcomes
- Primary objective Treatment of primary membranous nephropathy with conventional clinical protocols and observation of its effectiveness and safety in a wide population.
- Exploratory purpose
- Evaluate the genome-wide changes in kidney and peripheral blood during treatment.
- To evaluate the changes in the single-cell transcriptome of the kidney and peripheral blood during treatment.
- Evaluate the changes in the RNA transcriptome of the kidney and peripheral blood during treatment.
- Evaluate the changes in the renal and peripheral blood proteome during treatment.
- Assess the changes in the metabolome during treatment.
- Assess changes in the microbiome during treatment.
- Predict the effective population of rituximab by baseline renal pathological images.
- Primary outcome The complete response rate at 12 months;
- Secondary outcomes
- Response rates at 6, 12, 18 and 24 months (including the proportion of participants with complete response and partial response);
- Median remission time;
- Proportion of patients without recurrence at 12, 18 and 24 months;
- Median non-recurrence time;
- Cumulative dose of glucocorticoids;
- CD19+ cell count, anti-PLA2R antibody expression level;
- Renal function index: eGFR;
- Incidence of adverse events;
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed as primary membranous nephropathy (PMN) by renal biopsy, with indications for immunosuppressive therapy.
Key inclusion criteria (2 listed)
- 1. Diagnosed as primary membranous nephropathy (PMN) by renal biopsy; 2. Aged over 18 years; 3. An average 24-hour urine protein ≥ 3.5g twice a week after treatment with ACE inhibitors or ARBs for at least 3 months.
- -
Key exclusion criteria (4 listed)
- With secondary membranous nephropathy (such as hepatitis B and C, systemic lupus erythematosus, drug therapy, malignant tumors and other secondary causes);
- Active infection, such as active hepatitis B or hepatitis C, tuberculosis (evidence of active tuberculosis infection within 1 year), or human immunodeficiency virus HIV infection (positive for anti-HIV antibodies), etc.
- A history of immunodeficiency, including other acquired or congenital immunodeficiency diseases, or organ transplantation.
- -
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
The complete response rate at 12 months
Time frame: 12 months
The complete response rate at 12 months
8 secondary outcomes
Response rates at 6, 12, 18 and 24 months (including the proportion of participants with complete response and partial response)
Time frame: 24 months
Median remission time
Time frame: 24 months
Proportion of patients without recurrence at 12, 18 and 24 months
Time frame: 24 months
Median non-recurrence time
Time frame: 24 months
Cumulative dose of glucocorticoids
Time frame: 24 months
CD19+ cell count, anti-PLA2R antibody expression level
Time frame: 24 months
Renal function index: eGFR
Time frame: 24 months
Incidence of adverse events
Time frame: 24 months
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 22 Aug 2025.
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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.
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 Wei Chen 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 2 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: looking for participants now, as of the sponsor's last update on 22 Aug 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?
Contact Wei Chen (8602087769673, chenwei99@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The complete response rate at 12 months (time frame: 12 months). 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 Aug 2025; AzTrials last refreshed its copy on 1 Nov 2026.