Date

2025-06-25

Protocol

Protocol changed

Item Changed

Inclusion criteria

Previous Version

• Subjects ? 18 years of age and of local legal consenting age at the time of signing the informed consent. • Subject has source-verified biopsy-confirmed IgAN. • Subject is on a stable and maximally tolerated dose of authorized ACEI and/or ARB (as per local SOC and applicable guidelines) for at least 3 months prior to screening. Furthermore, subjects who are on a stable dose of SGLT2i therapy for IgAN, in addition to ACEIs and/or ARBs, may participate in the trial if treatment was initiated at least 3 months prior to screening. Subjects who are unable to tolerate ACEI and/or ARB therapy may be eligible for participation in the trial if their overall management of IgAN, including blood pressure control, is as per local SOC and applicable guidelines. • Subject has screening urine protein/creatinine ratio (uPCR) ? 0.75 g/g or urine protein ? 1.0 g/day, as measured from 24-hour urine samples (mean of the two 24-hour urine samples collected up to 2 weeks apart at screening) and when the o subject is considered to be in steady-state. o Subject has eGFR ? 30 mL/min/1.73 m2, calculated using the CKD-EPI equation. o Subjects with an eGFR of 30 to 45 L/min/1.73m2 are required to have had a kidney biopsy performed within 36 months of the screening visit. o For the exploratory cohort only: subject has eGFR of 20 to 30 mL/min/1.73 m2, calculated using the CKD-EPI equation. o Serum creatinine assessments for the determination of eGFR should be taken when the subject is considered to be in a steady-state without recent changes in volume status, medications that could impact the result (eg, nonsteroidal anti-inflammatory drugs [NSAIDs], aminoglycosides, trimethoprim, cimetidine, pyrimethamine, fenofibrate, or creatine supplements), or changes in dietary protein intake. • Ability to provide written informed consent prior to initiation of any trial-specific procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial.

Next Version

1. Subjects ? 18 years of age and of local legal consenting age at the time of signing the informed consent. 2. Subject has source-verified biopsy-confirmed IgAN. 3. Subject is on a stable and maximally tolerated dose of authorized ACEI and/or ARB (as per local SOC and applicable guidelines) for at least 3 months prior to screening. Furthermore, subjects who are on a stable dose of SGLT2i therapy for IgAN, in addition to ACEIs and/or ARBs, may participate in the trial if treatment was initiated at least 3 months prior to obtaining the initial screening urine collection. Subjects who are unable to tolerate ACEI and/or ARB therapy may be eligible for participation in the trial if their overall management of IgAN, including blood pressure control, is as per local SOC and applicable guidelines. 4. Subject has screening uPCR ? 0.75 g/g or urine protein ? 1.0 g/day, as measured from 24-hour urine samples (geometric mean of the two 24-hour urine samples collected up to 2 weeks apart at screening) and when the subject is considered to be in steady-state. 5. Subject has eGFR ? 30 mL/min/1.73 m2, calculated using the 2021 CKD-EPI equation. Subjects with an eGFR of 30 to 44 mL/min/1.73 m2 are required to have had a kidney biopsy performed within 36 months of the screening visit. For the exploratory cohort only: subject has eGFR of 20 to 29 mL/min/1.73 m2, calculated using the 2021 CKD-EPI equation. Serum creatinine assessments for the determination of eGFR should be taken when the subject is considered to be in a steady-state without recent changes in volume status, medications that could impact the result (eg, nonsteroidal anti-inflammatory drugs [NSAIDs], aminoglycosides, trimethoprim, cimetidine, pyrimethamine, fenofibrate, or creatine supplements), or changes in dietary protein intake. 6. Ability to provide written informed consent prior to initiation of any trial-specific procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial.