Renal outcomes trial (FIDELIO-DKD)*: exploratory analysis of adult patients with CKD associated with T2D

The relative reduction in UACR was 31% greater with KERENDIA vs placebo at month 4 and remained stable thereafter1,2

On top of standard of care, KERENDIA reduced UACR by 31% vs placebo at 4 months

Geometric mean UACR (mg/g) at baseline ± geometric SD:

• KERENDIA: 798.79±2.65

• Placebo: 814.73±2.67

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In the CV outcomes trial§ (FIGARO-DKD)

Similar placebo-corrected relative reduction in UACR of 32% was shown from baseline to month 4 with KERENDIA (95% CI: 30-35%) and remained stable for the duration of the trial.1

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In the CV outcomes trial§ (FIGARO-DKD)

Similar placebo-corrected relative reduction in UACR of 32% was shown from baseline to month 4 with KERENDIA (95% CI: 30-35%) and remained stable for the duration of the trial.1

In patients with CKD associated with T2D

The ADA now recommends a UACR reduction goal of ≥30% in patients with CKD who have ≥300 mg/g urinary albumin3

*The primary composite endpoint of FIDELIO-DKD consisted of kidney failure, a sustained decline of ≥40% in eGFR, or renal death.1

FIGARO-DKD (N=7352) and FIDELIO-DKD (N=5674) were randomized, double-blind, placebo-controlled, multicenter trials with median follow-up periods of 3.4 and 2.6 years, respectively.1

All patients were to be receiving the maximum tolerated doses of an ACEi or ARB.1

§The primary composite endpoint of FIGARO-DKD consisted of CV death, non-fatal MI, non-fatal stroke, or hospitalization for HF.1


ACEi=angiotensin-converting enzyme inhibitor; ADA=American Diabetes Association®; ARB=angiotensin receptor blocker; CKD=chronic kidney disease; CV=cardiovascular; eGFR=estimated glomerular filtration rate; HF=heart failure; MI=myocardial infarction; SD=standard deviation; T2D=type 2 diabetes; UACR=urine albumin-to-creatinine ratio.


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)



  • Concomitant use with strong CYP3A4 inhibitors
  • Patients with adrenal insufficiency


  • 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


  • 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%)


  • 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


  • 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.

References: 1. KERENDIA (finerenone) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; September 2022. 2. Bakris GL, et al; FIDELIO-DKD Investigators. N Engl J Med. 2020;383(23):2219-2229. doi:10.1056/NEJMoa2025845. 3. American Diabetes Association® Professional Practice Committee; Draznin B, et al. Diabetes Care. 2022;45(suppl 1):S144-S184.