Primary Membranous NephropathyPhase 4NCT06573411
Efficacy and Safety of Finerenone in Patients With Primary Membranous Nephropathy
A Phase 4 study testing ACEI/ARB+ finerenone and ACEI/ARB in people with Primary Membranous Nephropathy, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
This is a prospective, randomized, multicenter, controlled trial. One hundred sixteen patients with primary membranous nephropathy (PMN) will be randomly divided into the intervention and control groups. The intervention group will be administered maximum tolerable dose of ACEI/ARB and finerenone 20 mg QD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Membranous Nephropathy
- What is being tested?
- ACEI/ARB+ finerenone and ACEI/ARB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2024to 30 Oct 2026
- Phase
- Phase 4
- 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
Who may be able to join
- Adults (age≥18,and ≤75) with primary MN.
- Administration of the maximum tolerable dose of ACEI/ARB for ≥4 weeks.
- BP ≤140/90 mmHg.
- Urine protein content of 1.0-5.0 g/d.
- eGFR ≥60 (CKD-EPI).
- Postmenopausal or postoperatively infertile status or on medical contraception (considering the potential risk of thromboembolism in patients with kidney disease) in women.
- Voluntary signing of informed consent.
Who cannot join
- Type 1 or type 2 diabetes. Patients with a recent history of steroid-induced diabetes were eligible with renal biopsy showing no evidence of secondary diabetic nephropathy within 6 months before the screening period.
- Patients with secondary membranous nephropathy (e.g., due to hepatitis B and C, systemic lupus erythematosus, drug therapy, malignant tumors and other secondary causes).
- Uncontrolled arterial hypertension.
- Treatment with glucocorticoids, immunosuppressants and/or biological agents in the past 6 months.
- Treatment with any other study drug within the last month.
- Females with a positive pregnancy screening test, lactating or planning to become pregnant in the next 24 months. Female or male patients unwilling to use contraceptive methods throughout the study.
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- A history of mental illness.
- Laboratory tests meeting the following criteria:
- Hemoglobin levels <80 g/L;
- Platelet count <80×109/L;
- Neutrophil count <1.0×109/L;
- Aspartate aminotransferase (AST) or amino aminotransferase (ALT) >2.5 times the upper limit of normal, except in relation to the primary disease.
- Very high-risk cases (life-threatening nephrotic syndrome or unexplained rapid deterioration of renal function).
- Unsuitability for inclusion in the trial as judged by the investigator.
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: Efficacy and Safety of Finerenone in Patients With Primary Membranous Nephropathy: A Prospective, Randomized, Controlled, Multicenter Clinical Study
This is a prospective, randomized, multicenter, controlled trial. One hundred sixteen patients with primary membranous nephropathy (PMN) will be randomly divided into the intervention and control groups. The intervention group will be administered maximum tolerable dose of ACEI/ARB and finerenone 20 mg QD. Control patients will be administered maximum tolerable dose of ACEI/ARB. The primary endpoint is the relative change in urinary protein content from baseline to 6 months.
Read the detailed description
After more than 4 weeks of maximum tolerated dose of ACEI/ARB, the patients will be randomly divided into the control and intervention groups in a 1:1 ratio. The intervention group will then be administered finerenone 20 mg QD, while control cases will continue on their ACEI/ARB therapy.
- Conditions
- Primary Membranous Nephropathy
- Being tested
- ACEI/ARB+ finerenone, ACEI/ARB
- Keywords
- finerenone, urinary protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACEI/ARB+ finerenoneDrug
The intervention group will be administered maximum tolerable dose of ACEI/ARB and finerenone 20 mg QD.
ACEI/ARBDrug
Control patients will be administered maximum tolerable dose of ACEI/ARB.
| Study group | Role | What they receive |
|---|---|---|
| ACEI/ARB+finerenone | Experimental | The intervention group will be administered maximum tolerable dose of ACEI/ARB and finerenone 20 mg QD. Receives: Drug: ACEI/ARB+ finerenone |
| ACEI/ARB | Active comparator | Control patients will be administered maximum tolerable dose of ACEI/ARB. Receives: Drug: ACEI/ARB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change in urinary protein content from baseline to 24 weeks.
To evaluate the effects of ACEI/ARB combined with finerenone on proteinuria in patients with PMN compared to ACEI/ARB alone. The primary outcome of this study is the change in 24-hour urinary protein excretion (24h UTP) from baseline at week 24. The primary analysis of the study is planned to be performed using an Analysis of Covariance (ANCOVA) model. In this model, the treatment group is included as a fixed effect factor, the 24h UTP value at week 24 serves as the dependent variable, and the baseline UTP level is adjusted as a covariate. The main purpose of the analysis is to compare the changes in UTP at week 24 among different treatment groups while controlling for baseline differences between patients. The model will estimate the least squares means (LS-means) and provide the treatment difference between each pair of treatment groups, along with their two-sided 95% confidence intervals and p-values.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start30 Sep 2024
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (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.
- More trials run by First Affiliated Hospital, Sun Yat-Sen 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Chen, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573411
- Sponsor's protocol ID
- FIRPRO-PMN
- Status last verified
- Apr 2026
- First submitted
- 24 Aug 2024
- Last updated
- 8 Apr 2026
- 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 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Finerenone in Patients With Primary Membranous Nephropathy: A Prospective, Randomized, Controlled, Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT06573411
- Acronym / sponsor ID
- FIRPRO-PMN
- Conditions
- Primary Membranous Nephropathy
- Keywords
- finerenone, urinary protein
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 27 Aug 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.
This is a prospective, randomized, multicenter, controlled trial. One hundred sixteen patients with primary membranous nephropathy (PMN) will be randomly divided into the intervention and control groups. The intervention group will be administered maximum tolerable dose of ACEI/ARB and finerenone 20 mg QD. Control patients will be administered maximum tolerable dose of ACEI/ARB. The primary endpoint is the relative change in urinary protein content from baseline to 6 months.
Detailed description
After more than 4 weeks of maximum tolerated dose of ACEI/ARB, the patients will be randomly divided into the control and intervention groups in a 1:1 ratio. The intervention group will then be administered finerenone 20 mg QD, while control cases will continue on their ACEI/ARB therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACEI/ARB+finerenone | Experimental | Drug: ACEI/ARB+ finerenoneThe intervention group will be administered maximum tolerable dose of ACEI/ARB and finerenone 20 mg QD. |
| ACEI/ARB | Active comparator | Drug: ACEI/ARBControl patients will be administered maximum tolerable dose of ACEI/ARB. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults (age≥18,and ≤75) with primary MN.
- Administration of the maximum tolerable dose of ACEI/ARB for ≥4 weeks.
- BP ≤140/90 mmHg.
- Urine protein content of 1.0-5.0 g/d.
- eGFR ≥60 (CKD-EPI).
Key exclusion criteria (14 listed)
- Type 1 or type 2 diabetes. Patients with a recent history of steroid-induced diabetes were eligible with renal biopsy showing no evidence of secondary diabetic nephropathy within 6 months before the screening period.
- Patients with secondary membranous nephropathy (e.g., due to hepatitis B and C, systemic lupus erythematosus, drug therapy, malignant tumors and other secondary causes).
- Uncontrolled arterial hypertension.
- Treatment with glucocorticoids, immunosuppressants and/or biological agents in the past 6 months.
- Treatment with any other study drug within the last month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACEI/ARB+ finerenoneThe intervention group will be administered maximum tolerable dose of ACEI/ARB and finerenone 20 mg QD. | Drug | ACEI/ARB+finerenone |
| ACEI/ARBControl patients will be administered maximum tolerable dose of ACEI/ARB. | Drug | ACEI/ARB |
Primary outcome
Relative change in urinary protein content from baseline to 24 weeks.
Time frame: 24 weeks
To evaluate the effects of ACEI/ARB combined with finerenone on proteinuria in patients with PMN compared to ACEI/ARB alone. The primary outcome of this study is the change in 24-hour urinary protein excretion (24h UTP) from baseline at week 24. The primary analysis of the study is planned to be performed using an Analysis of Covariance (ANCOVA) model. In this model, the treatment group is included as a fixed effect factor, the 24h UTP value at week 24 serves as the dependent variable, and the baseline UTP level is adjusted as a covariate. The main purpose of the analysis is to compare the changes in UTP at week 24 among different treatment groups while controlling for baseline differences between patients. The model will estimate the least squares means (LS-means) and provide the treatment difference between each pair of treatment groups, along with their two-sided 95% confidence intervals and p-values.
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 8 Apr 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ACEI/ARB+ finerenone and ACEI/ARB in people with Primary Membranous Nephropathy, run by First Affiliated Hospital, Sun Yat-Sen 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 7 inclusion and 14 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 8 Apr 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Relative change in urinary protein content from baseline to 24 weeks. (time frame: 24 weeks). 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 8 Apr 2026.