Indications
Dashboard
CKD Associated With T2D
HF LVEF ≥40%

In adult patients with CKD associated with T2D

KERENDIA was evaluated in >13,000 adult patients with CV risk

FIGARO-DKD and FIDELIO-DKD were phase 3, randomized, double-blind, placebo-controlled, multicenter trials with median
follow-up periods of 3.4 and 2.6 years, respectively.

Trials had reciprocal endpoints (time to first occurrence)

  • The CV composite endpoint consisted of CV death, nonfatal MI, nonfatal stroke, and HF hospitalization (HHF)
  • The renal composite endpoint consisted of kidney failure, sustained decline of ≥40% in eGFR, and renal death

CV outcomes trial

FIGARO-DKD1,2,11

(N=7352)

  • Primary composite CV endpoint
  • Secondary composite renal endpoint

Renal outcomes trial

FIDELIO-DKD1,3,11

(N=5674)

  • Primary composite renal endpoint
  • Secondary composite CV endpoint

In both trials, patients were well managed with standard-of-care background therapy, including a maximum-tolerated dose of an ACEi or ARB.

Trial design
Criteria and characteristics
Efficacy and safety overview

CKD=chronic kidney disease; CV=cardiovascular; eGFR=estimated glomerular filtration rate; HF=heart failure; HHF=hospitalization for heart failure; MI=myocardial infarction; T2D=type 2 diabetes.

Trial Design CV Data Renal Data UACR Safety

FIGARO-DKD and FIDELIO-DKD shared similar designs

*On top of maximum-tolerated dose of either ACEi or ARB. †Up-titration of study drug was encouraged after visit 2, provided potassium value was ≤4.8 mEq/L and eGFR was stable; down-titration was allowed any time after treatment initiation for safety reasons. ‡The purpose of the mandatory run-in period was to allow for optimization of participant standard-of-care medical therapies. This included ensuring that a patient was pretreated with a maximum-tolerated labeled dose of either an ACEi or an ARB (preferably without dose adjustments or switching to a different ACEi or ARB) for >4 weeks prior to the screening visit. §Visits at month 1, month 4, and every 4 months thereafter. II4 weeks and 5 days after last dose.

ACEi=angiotensin-converting enzyme inhibitor; ARB=angiotensin receptor blocker; CKD=chronic kidney disease; CV=cardiovascular; eGFR=estimated glomerular filtration rate; T2D=type 2 diabetes.

Key criteria and baseline characteristics

KERENDIA was studied across a broad range of CKD severity

FIGARO-DKD
FIDELIO-DKD

CV outcomes trial1,12,37

FIGARO-DKD (N=7352)

  • Primary composite CV endpoint
  • Secondary composite renal endpoint

Select inclusion criteria1

UACR of 30 to <300 mg/g and eGFR of 25 to 90mL/min/1.73 m2
or UACR of ≥300 mg/g and eGFR of >60 mL/min/1.73 m2

Select exclusion criteria1

Other conditions:

  • Symptomatic chronic HF with reduced ejection fraction (NYHA class II-IV)
  • Known significant nondiabetic kidney disease

Select baseline characteristics12,37

  • Median UACR of 308 mg/g
  • Median eGFR of 67.8 mL/min/1.73 m2

Renal outcomes trial1,12,37

FIDELIO-DKD (N=5674)

  • Primary composite renal endpoint
  • Secondary composite CV endpoint

Select inclusion criteria1

UACR of 30 to <300 mg/g, eGFR of 25 to <60mL/min/1.73 m2,
and diabetic retinopathy or UACR of ≥300 mg/g and eGFR of 25 to <75 mL/min/1.73 m2

Select exclusion criteria1

Other conditions:

  • Symptomatic chronic HF with reduced ejection fraction (NYHA class II-IV)
  • Known significant nondiabetic kidney disease

Select baseline characteristics12,37

  • Median UACR of 852 mg/g
  • Median eGFR of 44.3 mL/min/1.73 m2

CKD=chronic kidney disease; CV=cardiovascular; eGFR=estimated glomerular filtration rate; HF=heart failure; NYHA=New York Heart Association; T2D=type 2 diabetes; UACR=urine albumin-to-creatinine ratio.

KERENDIA for CKD associated with T2D: efficacy and safety overview

FIGARO-DKD1,12

13%RRR

Primary CV composite endpoint

On top of standard of care, 13% RRR vs placebo, HR=0.87 (95% CI: 0.76-0.98), P=0.026

32%placebo-
corrected RR

Exploratory analysis1

UACR reduction relative to placebo on top of standard of care: 32%
(95% CI: 30-35%), at month 4

Secondary renal composite endpoint

The key secondary composite of kidney failure, sustained eGFR decline of ≥40%, or renal death occurred in 350 patients in the KERENDIA group (9.5%) and 395 patients in the placebo group (10.8%) (HR=0.87 [95% Cl: 0.76-1.01]). The difference was not statistically significant

FIDELIO-DKD1

18%RRR

Primary renal composite endpoint

On top of standard of care, 18% RRR vs placebo, HR=0.82 (95% CI: 0.73-0.93), P=0.001

31%placebo-
corrected RR

Exploratory analysis1

UACR reduction relative to placebo on top of standard of care: 31%
(95% CI: 29-34%), at month 4

14%RRR

Secondary CV composite endpoint

On top of standard of care, 14% RRR vs placebo, HR=0.86 (95% CI: 0.75-0.99), P=0.034

Safety: pooled data FIGARO-DKD and FIDELIO-DKD1

Adverse reactions reported in ≥1% of patients taking KERENDIA and more common than placebo

Hyperkalemia:
14% (KERENDIA: n=912/6510)
vs 6.9% (placebo: n=448/6489)

Hypotension:
4.6% (KERENDIA: n=302/6510)
vs 3.0% (placebo: n=194/6489)

Hyponatremia:
1.3% (KERENDIA: n=82/6510)
vs 0.7% (placebo: n=47/6489)

CI=confidence interval; CKD=chronic kidney disease; CV=cardiovascular; eGFR=estimated glomerular filtration rate; HR=hazard ratio; RR=relative reduction; RRR=relative risk reduction; T2D=type 2 diabetes; UACR=urine albumin-to-creatinine ratio.