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
egfr_uacr_graph
egfr_uacr

Kerendia was evaluated in a large phase 3 clinical trial program

phase 3 clinical trial
phase 3 clinical trial

Study designs for FIGARO-DKD and FIDELIO-DKD

Study designs for FIGARO-DKD and FIDELIO-DKD
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 m2)

67.6

68.0

44.4

44.3

eGFR <45 mL/min/1.73 m2 (% 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

heat map

Select inclusion and exclusion criteria

inclusion and exclusion criteria
inclusion and exclusion criteria