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Firialta was evaluated in >5,700 patients with early-to late-stage CKD1*

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

FIDELIO-DKD TRIAL
(RENAL-FOCUSED)3

Primary composite endpoint:

  • Kidney failure
  • Sustained decline of ≥40% in eGFR
  • Kidney death
     

FIGARO-DKD TRIAL
(CV-FOCUSED)2

Primary composite endpoint:

  • CV death
  • Non-fatal MI
  • Non-fatal stroke
  • HF hospitalisation
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Firialta was evaluated in a large phase 3 clinical trial program1

FIDELIO-DKD TRIAL

Kidney failure and disease
progression
(N=5734†)3

FIGARO-DKD TRIAL

CV mortality and morbidity
(N=7437†)2

FIDELITY

Prespecified pooled analysis
(N=13,171†)1

Study designs for FIDELIO-DKD1,4,5

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Patient characteristics were well-balanced between groups in both trials2,3

 
FIDELIO-DKD
Baseline Characteristics
Firialta
(n=2833)
Placebo
(n=2841)
Mean eGFR (mL/min/1.73 m2)
44.4
44.3
eGFR <45 mL/min/1.73 m2 (% of patients)
54.4
55.4
History of CVD (% of patients)
 
 
Coronary artery diseas
29.7
30.3
MI
13.3
13.7
Peripheral arterial occlusive disease
16.6
15.9
Ischemic stroke
11.6
12.7
Heart failure (% of patients)
6.9
8.5
Urinary albumin-to-creatinine ratio
 
 
Median (IQR) 
833 mg/g
867 mg/g
Glycated haemoglobin (%)
7.7±1.3
7.7±1.4
Systolic blood pressure (mmHg)
138.1±14.3
138.0±14.4
Select baseline medications (% of patients)
 
 
ACEi§
33.5
34.9
ARB§
66.3
65.0
Glucose-lowering therapies
97.0
97.7
Insulin
64.1
63.1
Metformin
44.2
43.6
GLP-1 receptor agonists
6.7
7.2
SGLT2 inhibitors
4.4
4.8
Statins
74.3
74.3
Antiplatelet agents
57.6
56.1
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Firialta was studied in a wide variety of patients with CKD and T2D, across disease stages1

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Select inclusion and exclusion criteria2,3

 
FIDELIO-DKD
Inclusion criteria
eGFR/
albuminuria
eGFR 25 to <60 mL/min/1.73 m2
with microalbuminuria
and diabetic retinopathy

OR

eGFR 25 to <75 mL/min/1.73 m2
with macroalbuminuria
Medications
Treated with standard-of-care background therapy, including maximum tolerated labelled dose of either an ACEi or an ARB
Serum
potassium
Serum potassium ≤4.8 mEq/L at screening
Exclusion criteria
Other
conditions
Symptomatic chronic HF with reduced ejection fraction
(New York Heart Association class II-IV)
Known significant non-diabetic kidney disease

Select inclusion and exclusion criteria2,3

Inclusion criteria

eGFR/albuminuria

FIGARO-DKD

eGFR ≥60 mL/min/1.73 m2 
with macroalbuminuria 

OR

eGFR 25 to 90 mL/min/1.73 m2
with microalbuminuria

FIDELIO-DKD

eGFR 25 to <60 mL/min/1.73 m2 
with microalbuminuria and 
diabetic retinopathy

OR

eGFR 25 to <75 mL/min/1.73 m2
with macroalbuminuria 

Medications

Treated with standard-of-care
background therapy, including
maximum tolerated labelled dose
of either an ACEi or an ARB

Serum potassium

Serum potassium ≤4.8 mEq/L
at screening

Exclusion criteria

Other conditions

Symptomatic chronic HF with
reduced ejection fraction 
(New York Heart Association class II-IV)

 

 

 

Known significant non-diabetic
kidney disease

Read about the clinical efficacy of Firialta
* 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.2,3
† Patients randomised.1-3
‡ 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.1
§ 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.3

 

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:

  • Bakris GL, et al; FIDELIO-DKD Investigators. N Engl J Med. 2020;383(23):2219-2229. doi:10.1056/NEJMoa2025. Return to content
  • Ruilope LM, et al. Am J Nephrol. 2019;50(5):345-356. doi:10.1159/000503712. Return to content
  • Bakris GL, et al. Am J Nephrol. 2019;50(5):333-344. doi:10.1159/000503713. Return to content

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