Date

2026-08-05

Protocol

Protocol changed

Item Changed

Secondary outcome

Previous Version

1. Change in albuminuria 2. Change in eGFR 3. Composite of >= 40% eGFR decline or kidney failure 4. All-cause mortality at 108 weeks 5. Number of cardiovascular events 6. Safety and tolerability of treatment 7. Change in quality of life

Next Version

1. Change in albuminuria between week 0 and 24 weeks 2. eGFR slope from week 0 to end of washout 3. Change in eGFR from week 0 to end of washout 4. Proportion of participants experiencing a >=40% eGFR decline, and proportion of participants developing kidney failure (defined as eGFR <15 mL/min/1.73m2 or chronic kidney replacement therapy start) at 108 weeks 5. Time to >=40% eGFR decline from week 0 or kidney failure 6. All-cause mortality at 108 weeks 7. Proportion of participants experiencing one of more cardiovascular events (cardiovascular death, hospitalised heart failure, myocardial infarction, stroke) between week 0 and week 108 8. Time to first occurrence of a cardiovascular event 9. Safety and tolerability of the intervention 10. Change in quality of life measured using the Quality of Life Impact Survey for Kidney Disease (QDIS CKD) at 6-monthly intervals from randomisation to week 108 developing kidney failure (defined as eGFR)