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
Key facts
- Who runs it
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Trial code
- Status
- Not yet recruiting
- Phase
- Phase 2
- People taking part
- 20 people, planned
- Starts
- 15 Dec 2026
- Expected to end
- 15 Sept 2028
- Type of study
- Interventional
- Treatments tested
- Sibeprenlimab
- Record updated
- 6 October 2026
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- 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
- 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 take part
- Have a kidney condition other than pMN, IM-FSGS or MCD, or have previously received a kidney transplant
- 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 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 a serious medical condition, including certain cancers, that could make study participation unsafe
- Have Type 1 diabetes or poorly controlled Type 2 diabetes
- Have a history of a severe allergic reaction to ingredients in the study drug
- Have uncontrolled high or low blood pressure
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
About the trial
What the trial wants to find out
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.
The group in the trial
- Sibeprenlimab Subcutaneous AdministrationTreatment being tested
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.
Treatment: Sibeprenlimab
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Fit questions
- Built from NCT07861113, who can take part
- Record updated
- 6 October 2026