Date

2024-12-18

Protocol

Protocol changed

Item Changed

Inclusion criteria

Previous Version

• Male or female of greater than or equal to 18 years of age. • Total urine protein excretion greater than 1.0 g per 24-hour or urine protein to creatinine ratio (UPCR) greater than 1.0 mg/mg based on a 24-hour urine sample during the Screening Period Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years. • eGFR greater than or equal to 30 mL/min/1.73 m2, as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. • On a stable prescribed regimen of RAASi for at least 12 weeks that is at the maximum labelled or tolerated dose at Screening. • Systolic blood pressure less than or equal to 150 mmHg and diastolic blood pressure less than or equal to 90 mmHg.

Next Version

1. Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study assessments 2. Adult male or female of ?18 years of age, or as per country specific legally or nationally recognized adult age, who provide written informed consent prior to performing any study assessments 3. Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years of the Screening Visit. 4. Total urine protein excretion ?1.0 g per 24-hour or urine protein to creatinine ratio (UPCR) ?1.0 mg/mg based on a 24-hour urine sample during the Screening Period 5. eGFR ?30 mL/min/1.73 m2 at screening, as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. 6. On a stable prescribed regimen of RASi (ACEi or ARB) for at least 12 weeks that is at the maximum labeled or tolerated dose at screening and from screening to study Day 1 • The subject is eligible if they do not tolerate RASi, provided their management of IgAN is standard of care (SoC) per local practice. This intolerance must be documented by the Investigator and discussed with the Medical Monitor. 7. Systolic blood pressure ?150 mmHg and diastolic blood pressure ?90 mmHg at screening 8. A female is eligible if she is not pregnant (i.e., after a confirmed menstrual period, a negative serum pregnancy test at screening and negative urine pregnancy test at Day 1), not breastfeeding (for at least 3 months prior to screening), and at least one of the following conditions applies: • Is not a woman of childbearing potential (WOCBP), as defined in Appendix 2. OR • Is a WOCBP who agrees to use a highly effective contraceptive method (i.e., has a failure rate of less than 1% per year), as listed in Appendix 2, at least 7 days prior to randomization, through 175 days after the last dose of study drug. See Appendix 2 for further details