Primary Membranous NephropathyPhase 2NCT07861113
A Study to Evaluate the Effectiveness and Safety of Sibeprenlimab in Participants With Primary Membranous Nephropathy, Immune-mediated Focal Segmental Glomerulosclerosis, and Minimal Change Disease
A Phase 2 study testing Sibeprenlimab in people with Primary Membranous Nephropathy and Minimal Change Disease, run by Otsuka Pharmaceutical Development & Commercialization, Inc..
Trial summary
This study will assess whether sibeprenlimab can help improve kidney disease in adults with primary membranous nephropathy (pMN) by reducing harmful antibodies linked to the disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Membranous Nephropathy, Minimal Change Disease, Focal Segmental Glomerulosclerosis
- What is being tested?
- Sibeprenlimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2026to 15 Sep 2028
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For people with pMN:
- Be experiencing their first episode of pMN, or have pMN that has returned after getting better (relapsed), with ongoing signs of significant kidney disease based on urine and blood tests.
- Have a blood test showing high levels of antibodies against PLA2R, a protein linked to pMN, and these antibody levels must not have improved significantly over the previous 8 to 24 weeks.
- Be taking a stable, maximum tolerated dose of a kidney-protective medication (such as an angiotensin converting enzyme (ACE) inhibitor or angiotensin II receptor blockers [ARB]) for at least 3 months before screening. Other medications that help reduce protein in the urine may also be allowed if the dose has remained unchanged for at least 3 months.
- For people with IM-FSGS or MCD:
- Have previously been diagnosed with IM-FSGS or MCD, confirmed by a kidney biopsy.
Show all 11Show fewer
- Currently have their disease well controlled, either in complete remission or partial remission, based on urine and blood test results.
- Have a disease that depends on immunosuppressive treatment (medications that reduce immune system activity), meaning:
- They need ongoing treatment with medications such as steroids or calcineurin inhibitors (CNIs) to keep the disease under control; and
- Within the last 18 months, they experienced a return of nephrotic syndrome (severe kidney disease symptoms) shortly after reducing or stopping immunosuppressive treatment.
- Be taking a stable dose of steroids or CNIs for at least 4 weeks before screening.
Who cannot join
- Have a kidney condition other than pMN, IM-FSGS or MCD, or have previously received a kidney transplant.
- Have another serious autoimmune disease that could affect their health or study results.
- Have a serious active infection, such as human immunodeficiency virus (HIV), hepatitis B, hepatitis C, tuberculosis (TB), or other significant chronic infections.
- Have uncontrolled high or low blood pressure.
- Have a serious medical condition, including certain cancers, that could make study participation unsafe.
- Have Type 1 diabetes or poorly controlled Type 2 diabetes.
Show all 12Show fewer
- Have recently received certain immune-suppressing treatments or other medications that could interfere with the study.
- Are currently participating in another clinical trial or have recently received an investigational medicine.
- Have a history of a severe allergic reaction to ingredients in the study drug.
- Have recent alcohol or substance abuse that could interfere with participation.
- Are unable to follow study procedures or attend required study visits.
- Note: Other protocol-specified Inclusion/Exclusion criteria may apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 2, Multicenter, Open-label Trial to Evaluate the Efficacy and Safety of Sibeprenlimab in Primary Membranous Nephropathy, Immune-mediated Focal Segmental Glomerulosclerosis, and Minimal Change Disease
This study will assess whether sibeprenlimab can help improve kidney disease in adults with primary membranous nephropathy (pMN) by reducing harmful antibodies linked to the disease. The study will also assess whether sibeprenlimab can help adults with immune-mediated focal segmental glomerulosclerosis (IM-FSGS) or minimal change disease (MCD) stay in remission and prevent their kidney disease from returning.
- Conditions
- Primary Membranous Nephropathy, Minimal Change Disease, Focal Segmental Glomerulosclerosis
- Being tested
- Sibeprenlimab
- Keywords
- Primary Membranous Nephropathy, Immune-mediated Focal Segmental Glomerulosclerosis, Minimal Change Disease
- Medical subject headings
- Nephrosis, Lipoid, Glomerulosclerosis, Focal Segmental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SibeprenlimabDrug
Also called VIS649
SC injection
| Study group | Role | What they receive |
|---|---|---|
| Sibeprenlimab Subcutaneous Administration | Experimental | Participants with primary membranous nephropathy (pMN) and immune-mediated focal segmental glomerulosclerosis (IM-FSGS) or minimal change disease (MCD) will receive a dose every four weeks for a total of seven doses. Receives: Drug: Sibeprenlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
pMN: Percentage of Participants With More Than (>) 80 Percent (%) Reduction From Baseline in Anti-Phospholipase A2 Receptor (PLA2R)
Measured: Week 25
IM-FSGS and MCD: Percentage of Participants Remaining in Remission (Complete or Partial Remission) at Week 25
Complete or partial remission will be determined from the urinary protein/creatinine ratio [uPCR] and serum albumin measurements. The criteria for complete remission include uPCR less than [<] 0.3 gram per gram [g/g] and normal serum albumin > 3.5 grams per liter [g/L]). Criteria for partial remission include uPCR < 1.0 g/g and normal serum albumin > 3.5 g/L.
Measured: Week 25
Secondary outcomes (8)
pMN: Change From Baseline in Anti-PLA2R
Measured: Baseline, Week 25
pMN, IM-FSGS, and MCD: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Measured: Up to Week 37
pMN, IM-FSGS, and MCD: Number of Participants With Clinically Significant Change in Laboratory Assessments From Baseline
Measured: Baseline, Week 37
pMN, IM-FSGS, and MCD: Number of Participants With Clinically Significant Change in Vital Sign Measurements From Baseline
Measured: Baseline, Week 37
pMN, IM-FSGS, and MCD: Number of Participants With Clinically Significant Change in Physical Examination Findings From Baseline
Measured: Baseline, Week 37
pMN, IM-FSGS, and MCD: Change From Baseline in Serum Drug Concentration
Measured: Baseline, Week 37
pMN, IM-FSGS, and MCD: Change From Baseline in A Proliferation Inducing Ligand (APRIL) Concentrations
Measured: Baseline, Week 37
pMN, IM-FSGS, and MCD: Number of Participants With Serum Anti-Drug Antibodies (ADA)
Measured: Up to Week 37
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start15 Dec 2026 (estimated)
- Primary completion15 Jun 2028 (estimated)
- Study completion15 Sep 2028 (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 Otsuka Pharmaceutical Development & Commercialization, Inc.The 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861113
- Sponsor's protocol ID
- 417-201-00132
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Open-label Trial to Evaluate the Efficacy and Safety of Sibeprenlimab in Primary Membranous Nephropathy, Immune-mediated Focal Segmental Glomerulosclerosis, and Minimal Change Disease
- ClinicalTrials.gov ID
- NCT07861113
- Acronym / sponsor ID
- 417-201-00132
- Conditions
- Primary Membranous Nephropathy, Minimal Change Disease, Focal Segmental Glomerulosclerosis
- Keywords
- Primary Membranous Nephropathy, Immune-mediated Focal Segmental Glomerulosclerosis, Minimal Change Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2026 (estimated)
- Primary completion
- 15 Jun 2028 (estimated)
- Study completion
- 15 Sep 2028 (estimated)
- First posted
- 6 Oct 2026 (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 study will assess whether sibeprenlimab can help improve kidney disease in adults with primary membranous nephropathy (pMN) by reducing harmful antibodies linked to the disease. The study will also assess whether sibeprenlimab can help adults with immune-mediated focal segmental glomerulosclerosis (IM-FSGS) or minimal change disease (MCD) stay in remission and prevent their kidney disease from returning.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sibeprenlimab Subcutaneous Administration | Experimental | Drug: SibeprenlimabParticipants with primary membranous nephropathy (pMN) and immune-mediated focal segmental glomerulosclerosis (IM-FSGS) or minimal change disease (MCD) will receive a dose every four weeks for a total of seven doses. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Be experiencing their first episode of pMN, or have pMN that has returned after getting better (relapsed), with ongoing signs of significant kidney disease based on urine and blood tests.
- Have a blood test showing high levels of antibodies against PLA2R, a protein linked to pMN, and these antibody levels must not have improved significantly over the previous 8 to 24 weeks.
- Be taking a stable, maximum tolerated dose of a kidney-protective medication (such as an angiotensin converting enzyme (ACE) inhibitor or angiotensin II receptor blockers [ARB]) for at least 3 months before screening. Other medications that help reduce protein in the urine may also be allowed if the dose has remained unchanged for at least 3 months.
- Have previously been diagnosed with IM-FSGS or MCD, confirmed by a kidney biopsy.
- Currently have their disease well controlled, either in complete remission or partial remission, based on urine and blood test results.
Key exclusion criteria (12 listed)
- Have a kidney condition other than pMN, IM-FSGS or MCD, or have previously received a kidney transplant.
- Have another serious autoimmune disease that could affect their health or study results.
- Have a serious active infection, such as human immunodeficiency virus (HIV), hepatitis B, hepatitis C, tuberculosis (TB), or other significant chronic infections.
- Have uncontrolled high or low blood pressure.
- Have a serious medical condition, including certain cancers, that could make study participation unsafe.
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 |
|---|---|---|
| SibeprenlimabAlso: VIS649SC injection | Drug | Sibeprenlimab Subcutaneous Administration |
Primary outcome
pMN: Percentage of Participants With More Than (>) 80 Percent (%) Reduction From Baseline in Anti-Phospholipase A2 Receptor (PLA2R)
Time frame: Week 25
IM-FSGS and MCD: Percentage of Participants Remaining in Remission (Complete or Partial Remission) at Week 25
Time frame: Week 25
Complete or partial remission will be determined from the urinary protein/creatinine ratio [uPCR] and serum albumin measurements. The criteria for complete remission include uPCR less than [<] 0.3 gram per gram [g/g] and normal serum albumin > 3.5 grams per liter [g/L]). Criteria for partial remission include uPCR < 1.0 g/g and normal serum albumin > 3.5 g/L.
8 secondary outcomes
pMN: Change From Baseline in Anti-PLA2R
Time frame: Baseline, Week 25
pMN, IM-FSGS, and MCD: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Time frame: Up to Week 37
pMN, IM-FSGS, and MCD: Number of Participants With Clinically Significant Change in Laboratory Assessments From Baseline
Time frame: Baseline, Week 37
pMN, IM-FSGS, and MCD: Number of Participants With Clinically Significant Change in Vital Sign Measurements From Baseline
Time frame: Baseline, Week 37
pMN, IM-FSGS, and MCD: Number of Participants With Clinically Significant Change in Physical Examination Findings From Baseline
Time frame: Baseline, Week 37
pMN, IM-FSGS, and MCD: Change From Baseline in Serum Drug Concentration
Time frame: Baseline, Week 37
pMN, IM-FSGS, and MCD: Change From Baseline in A Proliferation Inducing Ligand (APRIL) Concentrations
Time frame: Baseline, Week 37
pMN, IM-FSGS, and MCD: Number of Participants With Serum Anti-Drug Antibodies (ADA)
Time frame: Up to Week 37
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 6 Oct 2026.
- Otsuka Clinical Trial WebsiteLink provided by the sponsor.
- Otsuka Clinical Trial TransparencyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Related trials for Primary Membranous Nephropathy
Active, not recruitingPhase 1/2
An Open-label Study of Povetacicept in Autoantibody-Associated Glomerular Diseases
Lupus Nephritis, Immunoglobulin A Nephropathy
RecruitingPhase 2
A Study to Assess the Effect of Surovatamig in Adult Participants With Antibody-mediated Kidney Disease
Primary Membranous Nephropathy
RecruitingPhase 2
A Phase 2 Study of Budoprutug in Subjects With Primary Membranous Nephropathy
Primary Membranous Nephropathy
RecruitingPhase 2/3
Combination of Rituximab and Cyclosporine in the Treatment of Primary Membranous Nephropathy
Membranous Nephropathy
Active, not recruitingPhase 3
A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy
Primary Membranous Nephropathy
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sibeprenlimab in people with Primary Membranous Nephropathy and Minimal Change Disease, run by Otsuka Pharmaceutical Development & Commercialization, Inc..
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 11 inclusion and 12 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: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Otsuka Call Center (844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pMN: Percentage of Participants With More Than (>) 80 Percent (%) Reduction From Baseline in Anti-Phospholipase A2 Receptor (PLA2R) (time frame: Week 25). The study lists 2 primary outcomes in all. 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 6 Oct 2026.