Kerendia was evaluated in >13,000 patients with early-to late-stage CKD*

99.8% of patients were on the maximum tolerated dose of an ACEi or ARB, and 97.7% were on at least one glucose-lowering agent

FIGARO-DKD TRIAL (CV-FOCUSED)	FIDELIO-DKD TRIAL (RENAL-FOCUSED)
Primary composite endpoint: CV death Non-fatal MI Non-fatal stroke HF hospitalisation	Primary composite endpoint: Kidney failure Sustained decline of ≥40% in eGFR Kidney death

Kerendia was evaluated in a large phase 3 clinical trial program

Study designs for FIGARO-DKD and FIDELIO-DKD

Patient characteristics were well-balanced between groups in both trials

	FIGARO-DKD	FIGARO-DKD	FIDELIO-DKD	FIDELIO-DKD
Baseline Characteristics	Kerendia (n=3686)	Placebo (n=3666)	Kerendia (n=2833)	Placebo (n=2841)
Mean eGFR (mL/min/1.73 m ² )	67.6	68.0	44.4	44.3
eGFR ² (% of patients)	17.8	16.9	54.4	55.4
History of CVD (% of patients)
Coronary artery diseas	31.1	31.3	29.7	30.3
MI	17.4	16.8	13.3	13.7
Peripheral arterial occlusive disease	15.9	15.7	16.6	15.9
Ischemic stroke	12	11.6	11.6	12.7
Heart failure (% of patients)	7.9	7.7	6.9	8.5
Urinary albumin-to-creatinine ratio
Median (IQR)	302 mg/g	315 mg/g	833 mg/g	867 mg/g
Glycated haemoglobin (%)	7.7±1.4	7.7±1.4	7.7±1.3	7.7±1.4
Systolic blood pressure (mmHg)	135.8±14.0	135.7±14.1	138.1±14.3	138.0±14.4
Select baseline medications (% of patients)
ACEi ^§	42.8	42.6	33.5	34.9
ARB ^§	57.2	57.4	66.3	65.0
Glucose-lowering therapies	97.9	97.9	97.0	97.7
Insulin	54.9	53.7	64.1	63.1
Metformin	69.5	68.4	44.2	43.6
GLP-1 receptor agonists	8.4	6.6	6.7	7.2
SGLT2 inhibitors	8.5	8.3	4.4	4.8
Statins	69.2	71.8	74.3	74.3
Antiplatelet agents	55.5	53.3	57.6	56.1

Kerendia was studied in a wide variety of patients with CKD and T2D, across disease stages

Select inclusion and exclusion criteria

Read about the clinical efficacy of Kerendia

Abbreviations

^*2.4% of patients had baseline eGFR <25 mL/min/1.73 m² in the FIDELIO-DKD trial, and 0.4% in the FIGARO-DKD trial; 0.4% of patients had baseline UACR <30 mg/g in the FIDELIO-DKD trial, and 2.8% in the FIGARO-DKD trial.

^†Patients randomised.

^‡If serum potassium was ≤4.8 mmol/L and eGFR was stable, patients were encouraged to increase their dose from 10 to 20 mg once daily. If serum potassium was >4.8 mmol/L and/or eGFR was not stable, patients could decrease their dose from 20 to 10 mg once daily.

^§In the FIDELIO-DKD trial, 14 patients were not treated with either an ACEi or an ARB at baseline; 7 patients received treatment with both an ACEi and an ARB.

ACEi=angiotensin-converting enzyme inhibitor; ARB=angiotensin receptor blocker; CKD=chronic kidney disease; CV=cardiovascular; CVD=cardiovascular disease; eGFR=estimated glomerular filtration rate; GFR=glomerular filtration rate; GLP-1=glucagon-like peptide 1; HF=heart failure; IQR=interquartile range; MI=myocardial infarction; SGLT2=sodium-glucose cotransporter 2; T2D=type 2 diabetes; UACR=urine albumin-to-creatinine ratio.

References

1
Agarwal R, et al. Eur Heart J. 2022;43(6):474-484. doi:10.1093/eurheartj/ehab777.
2
Pitt B, et al. N Engl J Med. 2021;385(24):2252-2263. doi:10.1056/NEJMoa2110956.
3
Bakris GL, et al; FIDELIO-DKD Investigators. N Engl J Med. 2020;383(23):2219-2229. doi:10.1056/NEJMoa2025.
4
Ruilope LM, et al. Am J Nephrol. 2019;50(5):345-356. doi:10.1159/000503712.
5
Bakris GL, et al. Am J Nephrol. 2019;50(5):333-344. doi:10.1159/000503713.