1.4.3-Renal

In adult patients with CKD associated with T2D

KERENDIA was proven to slow CKD progression on top of standard of care¹

FIDELIO-DKD TRIAL

Primary composite endpoint consisted of kidney failure,* sustained decline of ≥40% in eGFR, or renal death¹

PRIMARY COMPOSITE ENDPOINT

18% RRR vs placebo¹

HR=0.82 | 95% CI: 0.73-0.93 | P=0.001

ARR: 3.4%
(95% CI: 0.6-6.2)²⁸

NNT: 29
(95% CI: 16-166)
to prevent a primary composite endpoint event at 36 months²⁸

The treatment effect reflected a reduction in sustained decline in eGFR of ≥40% and progression to kidney failure. There were few renal deaths during the trial.¹

Subgroups

Renal outcomes from FIGARO-DKD^1,2

The key secondary composite outcome 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% CI: 0.76-1.01]). The difference was not statistically significant.

*Kidney failure was defined as chronic dialysis or kidney transplantation, or a sustained decrease in eGFR to <15 mL/min/1.73 m².

ARR=absolute risk reduction; CI=confidence interval; CKD=chronic kidney disease; CV=cardiovascular; HF LVEF=heart failure with left ventricular ejection fraction; HHF=hospitalization for heart failure; HR=hazard ratio; MI=myocardial infarction; NNT=number needed to treat; RRR=relative risk reduction; T2D=type 2 diabetes.

Trial Design CV Data Renal Data UACR Safety

IMPORTANT SAFETY INFORMATION AND INDICATIONS

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

Hypersensitivity to any component of this product
Concomitant use with strong CYP3A4 inhibitors
Patients with adrenal insufficiency

WARNINGS AND PRECAUTIONS:

Hyperkalemia: KERENDIA can cause hyperkalemia. The risk for developing hyperkalemia increases with decreasing kidney function and is greater in patients with higher baseline potassium levels or other risk factors for hyperkalemia

Measure serum potassium and eGFR in all patients before initiation of treatment with KERENDIA and dose accordingly. Do not initiate KERENDIA if serum potassium is >5 mEq/L. Measure serum potassium periodically during treatment with KERENDIA and adjust dose accordingly. More frequent monitoring may be necessary for patients at risk for hyperkalemia, including those on concomitant medications that impair potassium excretion or increase serum potassium.
Worsening of Renal Function in Patients with Heart Failure: KERENDIA can cause worsening of renal function in patients with heart failure. Rarely, severe events associated with worsening renal function, including events requiring hospitalization, have been observed

Measure eGFR in all patients before initiation of treatment or with dose titration of KERENDIA and dose accordingly. Initiation of KERENDIA in patients with heart failure and an eGFR <25 mL/min/1.73 m² is not recommended. Measure eGFR periodically during maintenance treatment with KERENDIA in patients with heart failure. Consider delaying up-titration or interrupting treatment with KERENDIA in patients who develop clinically significant worsening of renal function

MOST COMMON ADVERSE REACTIONS:

CKD associated with T2D: From the pooled data of FIDELIO-DKD and FIGARO-DKD, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (14% vs 6.9%), hypotension (4.6% vs 3%), and hyponatremia (1.3% vs 0.7%).
HF LVEF ≥40%: From FINEARTS-HF, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (9.7% vs 4.2%), hypotension (7.6% vs 4.7%), and hyponatremia (1.9% vs 0.9%). Events related to worsening renal function were reported more frequently in the KERENDIA group (18%) compared with placebo (12%).

DRUG INTERACTIONS:

Strong CYP3A4 Inhibitors: Concomitant use of KERENDIA with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant intake of grapefruit or grapefruit juice.
Moderate and Weak CYP3A4 Inhibitors: Monitor serum potassium during drug initiation or dosage adjustment of either KERENDIA or the moderate or weak CYP3A4 inhibitor, and adjust KERENDIA dosage as appropriate.
Strong and Moderate CYP3A4 Inducers: Avoid concomitant use of KERENDIA with strong or moderate CYP3A4 inducers.
Sensitive CYP2C8 Substrates at KERENDIA 40mg: Monitor patients more frequently for adverse reactions caused by sensitive CYP2C8 substrates if KERENDIA 40mg is co-administered with such substrates, since minimal concentration changes may lead to serious adverse reactions.

USE IN SPECIFIC POPULATIONS:

Lactation: Avoid breastfeeding during treatment with KERENDIA and for 1 day after treatment.
Hepatic Impairment: Avoid use of KERENDIA in patients with severe hepatic impairment (Child Pugh C) and consider additional serum potassium monitoring with moderate hepatic impairment (Child Pugh B).

INDICATIONS:

KERENDIA (finerenone) is indicated to reduce the risk of:

sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) (10mg, 20mg tablets)
cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (HF LVEF) ≥40% (10mg, 20mg, 40mg tablets)

Please see the full Prescribing Information for KERENDIA.

CKD=chronic kidney disease; eGFR=estimated glomerular filtration rate; HbA1c=glycated hemoglobin; SBP=systolic blood pressure; T2D=type 2 diabetes; UACR=urine albumin-to-creatinine ratio.

REFERENCES

KERENDIA was proven to slow CKD progression on top of standard of care1

FIDELIO-DKD TRIAL

Renal outcomes from FIGARO-DKD1,2

The treatment effect with KERENDIA was generally consistent across subgroups1,28

Prespecified, exploratory subgroups included:

eGFR at baseline

SBP at baseline

UACR at baseline

HbA1c at baseline

KERENDIA was proven to slow CKD progression on top of standard of care¹

Renal outcomes from FIGARO-DKD^1,2

The treatment effect with KERENDIA was generally consistent across subgroups^1,28