Date

2024-12-16

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

• 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.