KERENDIA: evaluated in the largest CKD trial program3
>13,000 earlier*- and later-stage† adult patients with CKD associated with T2D3
FIGARO-DKD and FIDELIO-DKD were randomized, double-blind, placebo-controlled, multicenter trials with median follow-up periods of 3.4 and 2.6 years, respectively.13 To learn more, click on each trial design below:
FIGARO-DKD
(N=7352)
*Majority earlier-stage (1-2) CKD patients10,16
(defined as eGFR ≥60 mL/min/1.73 m2 with albuminuria)
FIDELIO-DKD
(N=5674)
†Majority later-stage (3-4) CKD patients4,10
(defined as eGFR <60 mL/min/1.73 m2 with albuminuria)
Trials had reciprocal endpoints (assessed in a time-to-event analysis)13
- The CV composite endpoint consisted of CV death, non-fatal MI, non-fatal stroke, or hospitalization for HF
- The renal composite endpoint consisted of kidney failure, sustained decline of ≥40% in eGFR, or renal death
Select inclusion and exclusion criteria across both trials13
Baseline trial population characteristics
FIDELIO-DKD13
- Mean age: 66 years
- Male: 70%
- 63% White, 25% Asian, and 5% Black (24% Black in the US)
- Mean eGFR: 44 mL/min/1.73 m2
- eGFR of <45 mL/min/1.73 m2: 55%
- Median UACR: 852 mg/g
- Mean HbA1c: 7.7%
- ACVD: ~46%
- Heart failure: 8%
- Mean BP: 138/76 mmHg
- ACEi or ARB: 99.8%
- Antidiabetic agent: ~97%
- Statin: 74%
- Antiplatelet agent: 57%
FIGARO-DKD13
- Baseline eGFR was higher in the FIGARO-DKD trial (mean eGFR was 68 mL/min/1.73 m2, with 62% of patients having an eGFR of ≥60 mL/min/1.73 m2) and median UACR was lower (308 mg/g) than the FIDELIO-DKD trial. Otherwise, baseline patient characteristics and background therapies were similar in the 2 trials
ACEi=angiotensin-converting enzyme inhibitor; ACVD=atherosclerotic cardiovascular disease; ARB=angiotensin receptor blocker; BP=blood pressure; CKD=chronic kidney disease; CV=cardiovascular; eGFR=estimated glomerular filtration rate; HbA1c=glycated hemoglobin; HF=heart failure; MI=myocardial infarction; NEJM=New England Journal of Medicine; T2D=type 2 diabetes; UACR=urine albumin-to-creatinine ratio.
INDICATION:
KERENDIA is indicated to reduce the risk of sustained 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)
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS:
- 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 >5.0 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
MOST COMMON ADVERSE REACTIONS:
- From the pooled data of 2 placebo-controlled studies, 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 3.9%), and hyponatremia (1.3% vs 0.7%)
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
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)
Please read the Prescribing Information for KERENDIA.
