Date

2026-01-19

Protocol

Protocol changed

Item Changed

Inclusion criteria

Previous Version

1. Adults, aged 18-65 years 2. Biological males and females 3. Diagnosis of one of the following glomerular kidney diseases: diabetic nephropathy; primary focal segmental glomerulosclerosis; treatment resistant-minimal change disease; primary IgA nephropathy; primary membranous nephropathy 4. eGFR greater than or equal to 30 mL/min/1.73 m2

Next Version

1. Adults of any race, age 18 to 75 years. 2. 2. Diagnosis of one of the following glomerular kidney diseases with elevated UACR or UPCR based on 24-hour urine during the Screening period: a. DN: Clinical diagnosis of DN; Type 1 or Type 2 diabetes mellitus with chronic kidney disease (CKD) not secondary to other etiologies; UACR 500- 3500 mg albumin/g creatinine. b. FSGS or TR-MCD: Diagnosis based on renal biopsy within 7 years of Screening with UPCR ? 1.0 g protein/g creatinine at Screening i. For FSGS, disease-causing genetic mutation may be considered instead of renal biopsy. ii. TR-MCD must also lack response to at least > 16 weeks of glucocorticoid therapy. c. IgAN: Diagnosis based on renal biopsy within 7 years of Screening with UPCR ? 0.75 g protein/g creatinine at Screening. d. PMN: Diagnosis based on renal biopsy within 7 years of Screening with i, ii, or iii below, and UPCR not decreasing > 50% in the last 6 months: i. UPCR ? 5 g protein/g creatinine after maximum tolerated standard of care (SoC) for ? 3 months, or ii. UPCR ? 4 g protein/g creatinine after maximum tolerated SoC for ? 6 months, or iii. UPCR ? 3.5 g protein /g creatinine and serum albumin ? 3.0 g/dL prior to Screening. 3. Estimated glomerular filtration rate (eGFR), calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI 2021) equation method, ? 30 mL/min/1.73 m2 at Screening. 4. If receiving an angiotensin-converting enzyme (ACE) inhibitor, an angiotensin II receptor blocker (ARB), endothelin and angiotensin II receptor antagonist, sodium glucose co-transporter-2 (SGLT2) inhibitors, glucagon-like peptide-1 (GLP-1) agonists, and/or aldosterone antagonists, subjects should be stable on maximum tolerated daily dose as per local standard for at least 12 weeks prior to Screening and maintain prescribed dose for the duration of the study unless a safety issue is associated with that medication. 5. No longer receiving budesonide and completed a 9-month course of treatment, or unable to tolerate budesonide treatment or agree not to initiate budesonide for the duration of study, except budesonide administered by inhalation is allowed. 6. If taking corticosteroid therapy (i.e., prednisone), stable dose of ? 15 mg/day or ? 30 mg on alternate days for ? 8 weeks prior to Screening with no plan to change the dose or regimen during the study. 7. Persons of child-bearing potential must have a negative pregnancy test and must agree to either abstain from sex or to use highly effective method(s) of birth control based on the subject’s preferred and usual lifestyle from the date of dosing through the duration of the study and for at least 24 weeks after their last dose of study treatment. The barrier method should only be used if local regulatory authorities also consider this to be a highly effective method of birth control. 8. Persons of non-childbearing potential are at least 12 months postmenopausal confirmed by follicle stimulating hormone (FSH) > 40 IU or 6 weeks after surgical bilateral oophorectomy with or without hysterectomy OR post-hysterectomy. 9. All biological male subjects of childbearing potential who are heterosexually active must agree to use a highly effective method of barrier contraception for the duration of the study and for at least 24 weeks after their last dose of study treatment. 10. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).