Table 1.

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

FIDELIO-DKD	FIGARO-DKD	Difference	DPV/DIVE Analysis
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

CKD chronic kidney disease; CKD-EPI Chronic Kidney Disease Epidemiology Collaboration; DKD diabetic kidney disease; eGFR estimated glomerular filtration rate; UACR urinary albumin-to creatinine ratio