Efficacy and Safety of Extended TARPEYO® Treatment Beyond 9 Months in Adult Patients with Primary IgA Nephropathy

Eligibility Criteria

• 1. Diagnosed IgAN with biopsy verification
• 2. Female or male participants ≥18 years of age
• 3. Completion of 9 months of treatment with TARPEYO® 16 mg QD at the Baseline visit
• 4. Access to retrospective local laboratory assessment data on UPCR and serum creatinine.
• 5. Proteinuria at Screening based on 2 consecutive measurements (24-hour urine collection) after informed consent, separated by at least 1 week and calculated by the central laboratory.
• * Proteinuria ≥0.5 g per day (≥500 mg per day) in 2 consecutive measurements, or
• * UPCR ≥0.3 g/gram in 2 consecutive measurements
• 6. On stable treatment with renin-angiotensin system (RAS) inhibitor therapy for at least 8 weeks prior to the Baseline visit. A stable dose is defined as a dose within 25% of the dose at Baseline
• 7. If on current treatment with sodium-glucose cotransporter-2 (SGLT2) inhibitor, the treatment should have been stable for at least 8 weeks prior to the Baseline visit. A stable dose is defined as a dose within 25% of the dose at Baseline
• 1. Participants who have been treated with systemic immunosuppressive medications including glucocorticosteroids (GCS) other than TARPEYO® during the TARPEYO® commercial treatment period. Topical or inhalation products containing GCS or immunosuppressants are allowed
• 2. Presence of other glomerulopathies (e.g., C3 glomerulopathy and/or diabetes nephropathy)
• 3. Presence of nephrotic syndrome (i.e., proteinuria \>3.5 g per day and serum albumin \<3.0 g/dL, with or without edema)
• 4. Presence of medical condition excluding continued TARPEYO® treatment, as assessed by the Investigator
• 5. On current or planned dialysis.
• 6. Undergone kidney transplant.
• 7. Poorly controlled diabetes mellitus or hypertension, as assessed by the Investigator.
• 8. Participants with known osteoporosis in the medium- or high-risk category according to the 2010 American College of Rheumatology recommendations.
• 9. Any medical or social circumstance making trial participation and/or TARPEYO® treatment unsuitable, as assessed by the Investigator.
• 10. Participants with clinically significant infections that put the participant at risk, at the discretion of the Investigator.
• 11. Participants unwilling or unable to meet the requirements of the protocol.
• 12. Intake of another investigational drug during trial, or during the preceding 9-month commercial TARPEYO® treatment period.
• 13. Females who are pregnant, breastfeeding, or plan to become pregnant in the trial period.
• 14. Participants taking potent inhibitors of cytochrome P450 (CYP) 3A4