Table 5 Recent clinical trials of MRA agents with kidney outcomes

 FIDELIO DKD [63]

Sept 2015–April 2020

978 sites in 48 countries

Adults with T2D and CKD (UACR 30 to <300 AND eGFR (CKD-EPI) 25 to <60 OR UACR 300-5000 AND eGFR 25 to <75), age ≥18 yrs, taking maximum tolerated dose of ACEi or ARB, serum potassium ≤4.8 mmol/L, HbA1c ≤12%

N=2833 finerenone, 10mg once daily titrated up to 20mg once daily as tolerated

N=2841 placebo once daily

BL: mean age 66 yrs, 70% male, 63% white, mean duration T2D 17 yrs, mean HbA1c 7.7%, mean eGFR 44, median UACR 852, mean serum potassium 4.37 mmol/L, 7% taking GLP-1 RA, 5% taking SGLT2i

Primary outcomes:

A) Kidney composite of kidney failure (ESKD or eGFR <15), sustained decrease of ≥40% in eGFR from BL for ≥4 weeks, or kidney-related death

B) Kidney failure

C) ESKD

D) eGFR <15

E) Sustained decrease of ≥40% in eGFR from BL for ≥4 weeks

F) Kidney-related death

Secondary outcomes

G) Change in UACR from BL to study month 4

H) Composite of kidney failure, sustained decrease of ≥57% from BL eGFR for ≥4 weeks, or kidney-related death

I) Sustained decrease of ≥57% from BL eGFR for ≥4 weeks

A) 0.82 (0.73–0.93)

B) 0.87 (0.72–1.05)

C) 0.86 (0.67–1.10)

D) 0.82 (0.67–1.01)

E) 0.81 (0.72–0.92)

F) --

G) Between group difference=0.69 (0.66, 0.71)

H) 0.76 (0.65, 0.90)

A) I) 0.68 (0.55–0.82)

 FIGARO DKD [64]

Sept 2015–Feb 2021; NOTE: COVID-19 caused trial disruption for 29% of pts, and temporary interruption of trial regiment for 10% of pts

975 sites in 48 countries

Adults with T2D, age ≥18 yrs, HbA1c <12%, with either UACR 30 to <300 AND eGFR (per CKD-EPI) 25 to 90 OR UACR 300-5000 AND eGFR ≥60, taking ACEi or ARB at maximum tolerated dose, serum potassium ≤4.8 mmol/L at screening

N=3686 finerenone, 10mg once daily titrated up to 20mg per day as tolerated

N=3666 placebo once daily

BL: mean age 64 yrs, 69% male, 72% white, mean HbA1c 7.7%, mean eGFR 68, median UACR 308, 8% taking SGLT2i, and 8% taking GLP-1 RA at BL, with additional 16% and 11%, respectively, starting over study period

A) Composite of 1st occurrence of kidney failure (ESKD or sustained decrease in eGFR <15), sustained decrease of ≥40% from BL eGFR for ≥4 weeks, or kidney-related death

B) 1st occurrence of kidney failure

C) ESKD

D) Sustained decrease in eGFR <15

E) sustained decrease of ≥40% from BL eGFR for ≥4 weeks

F) kidney-related death

G) Change in UACR from BL to study week 4

H) Composite of 1st occurrence of kidney failure, sustained decrease of ≥57% from BL eGFR for ≥4 weeks, or kidney-related death

I) sustained decrease of ≥57% from BL eGFR for ≥4 weeks

B) 0.87 (0.76–1.01)

C) 0.72 (0.49–1.05)

D) 0.64 (0.41–0.995)

E) 0.71 (0.43–1.16)

F) 0.87 (0.75–1.00)

G) –

H) Between group difference=0.68 (0.65–0.70)

I) 0.77 (0.60–0.99)

J) 0.76 (0.58–1.00)