Table 1 CKD definitions used in FIDELIO-DKD vs. FIGARO-DKD clinical trials [17, 18]

Patients with a clinical diagnosis of CKD based on either of the following criteria at the run-in and screening visits:

Patients with a clinical diagnosis of CKD based on either of the following criteria at the run-in and screening visits:

Patient is diagnosed with Persistent high albuminuria by following factors:- UACR ≥30 mg/g (≥3.4 mg/mmol) but <300 mg/g (<33.9 mg/mmol)- CKD-EPI showing eGFR ≥25 but <60 mL/min/1.73 m2 with the history of diabetic rectinopathy.

Patient is diagnosed with Persistent high albuminuria by following factors:- UACR ≥30 mg/g (≥3.4 mg/mmol) but <300 mg/g (<33.9 mg/mmol)- CKD-EPI showing eGFR ≥25 but ≤90 mL/min/1.73 m2 in the medical history

In FIDELIO-DKD in 10% of the patients with microalbuminuria, eGFR ≥ 60 mL/min/1.73 m² (CKD-EPI) a retinopathy was required for inclusion

All patients that fulfilled either criteria were included, retinopathy was disregarded

OR

OR

Patient is diagnosed with Persistent very high albuminuria by following factors:- UACR ≥300 mg/g (≥33.9 mg/mmol)- CKD-EPI showing eGFR ≥25 but <75 mL/min/1.73 m2

Patient is diagnosed with Persistent very high albuminuria by following factors:- UACR ≥300 mg/g (≥33.9 mg/mmol)- CKD-EPI showing eGFR ≥60 mL/min/1.73 m2

In FIDELIO-DKD no patients with macroalbuminuria, and eGFR ≥ 75 mL/min/1.73 m² (CKD-EPI) were included

In FIGARO-DKD no patients with macroalbuminuria but eGFR < 60 mL/min/1.73 m² (CKD-EPI) were included

All patients that fulfilled either criteria were included