Date

2026-01-19

Protocol

Protocol changed

Item Changed

Exclusion criteria

Previous Version

1. Currently pregnant or planning to become pregnant 2. History of organ transplantation 3. History of alcohol or substance use disorder 4. Acute dialysis or acute kidney injury within 6 months of screening 5. Any prior or current medical condition that, in the judgment of the Investigator, would prevent the subject from safely participating in and/or completing all study requirements

Next Version

1. Currently pregnant, breast-feeding, or planning to become pregnant within 12 months of Screening. 2. 2. History of organ or bone marrow transplantation, including renal transplantation. 3. Currently on an organ transplant waiting list or there is a reasonable possibility of undergoing an organ transplant within 10 months of Screening. 4. Body Mass Index (BMI) ? 40 kg/m2. 5. History of malignancy, unless in remission for at least 2 years other than basal cell or squamous cell skin carcinoma, cervical carcinoma in situ, or prostate cancer not expected to require treatment over the course of the study. 6. History of alcohol or substance use disorder within 12 months prior to Screening. 7. Uncontrolled systemic hypertension with systolic blood pressure >160 mmHg and diastolic blood pressure ? 100 mmHg at Screening. 8. Acute dialysis or acute kidney injury within 6 months prior to Screening. 9. Histological FSGS subtype of collapsing variant. 10. On renal biopsy, rapidly progressive glomerulonephritis (RPGN) and/or > 25% crescents and/or > 50% tubulointerstitial fibrosis on biopsy. 11. Secondary FSGS that develops as an adaptive response to glomerular hypertrophy or hyperfiltration including disorders associated with a reduced renal mass and/or renal vasodilation, such as unilateral renal agenesis. Other secondary FSGS associated with drugs and toxins (i.e., heroin, interferon, pamidronate) and viral infections (i.e., human immunodeficiency virus [HIV]). 12. Diagnosis of IgA vasculitis. 13. Secondary IgAN associated with cirrhosis, celiac disease, HIV infection, dermatitis herpetiformis, seronegative arthritis, small cell carcinoma, lymphoma, disseminated tuberculosis, bronchiolitis obliterans, inflammatory bowel disease, familial Mediterranean fever, etc. 14. Secondary membranous nephropathy associated with a history of drug use (such as excessive use of nonsteroidal anti-inflammatory drugs [NSAIDs]), infections (such as hepatitis B or C), autoimmune diseases (such as systemic lupus erythematosus [SLE]), or cancer. 15. Hospitalization for congestive heart failure (CHF) within 6 months, or cerebrovascular accident (CVA) or myocardial infarction (MI) within 3 months of Screening. 16. Life expectancy of less than 1 year at Screening. 17. Liver transaminase levels > 2 × ULN, active hepatobiliary disease, jaundice, and/or hepatitis. Gilbert’s syndrome is acceptable if direct bilirubin is ? ULN. 18. History of seizures or history of epilepsy. 19. History of serious mental illness. 20. Positive serology for HIV type 1 or 2, hepatitis B surface antigen, or hepatitis C RNA. 21. 21. Active or chronic tuberculosis. 22. History of inadequate venous access and/or experience of difficulty donating blood. 23. History of angioedema and/or anaphylactic reactions. 24. Any prior or current medical condition that, in the judgment of the Investigator, would prevent the subject from safely participating in and/or completing all study requirements. 25. Positive test for alcohol or illegal drugs of abuse at Screening or Day 0. 26. Treated with rituximab within 24 weeks of Screening, or cyclophosphamide, mycophenolate mofetil, azathioprine, calcineurin inhibitors, budesonide or abatacept within 12 weeks prior to Screening. 27. Participation in other interventional clinical studies within 30 days or 5 half-lives of experimental treatment (whichever is greater) prior to Screening.