Cardiometabolic & kidney

Slowing Progression of Cardiovascular Calcification With SNF472 in Patients on Hemodialysis: Results of a Randomized Phase 2b Study

CirculationPublished Randomised controlled trial

Authors' conclusion

Compared with placebo, SNF472 significantly attenuated the progression of coronary artery calcium and aortic valve calcification in patients with end-stage kidney disease receiving hemodialysis in addition to standard care.

Study context

Population
Adults with end-stage kidney disease receiving hemodialysis
Participants
92 / 91 / 91
Comparison
SNF472 vs placebo, in addition to standard therapy
  • SNF472 300 mgn = 92
  • SNF472 600 mgn = 91
  • Placebon = 91reference
Primary endpoint
Change in log coronary artery calcium volume score
Follow-up
Baseline to week 52
Methodological detailsdouble-blind, placebo-controlled, phase 2b
  • Double-blind
  • Placebo-controlled
  • Phase 2b

Primary result

As reported in the abstract

Mean change in coronary artery calcium volume score · week 52

SNF472 combined

11%

mean change · 95% CI 7–15

Placebo

20%

mean change · 95% CI 14–26

P = 0.016

Further findings

OutcomePlaceboP value
Aortic valve calcium volume score progressionSNF472 vs Placebo98% (95% CI 77–123)P < 0.001
Thoracic aorta calcium volume score progressionSNF472 vs Placebo28% (95% CI 19–38)P = 0.40
Death6%
  • Aortic valve calcium volume score progression: SNF472 14% (95% CI 5–24)
  • Thoracic aorta calcium volume score progression: SNF472 23% (95% CI 16–30)
  • Death: SNF472 4%

Safety

≥1 treatment-emergent adverse event

Discontinuation due to adverse events

≥1 treatment-emergent adverse event

Most adverse events were mild

Original publication

Slowing Progression of Cardiovascular Calcification With SNF472 in Patients on Hemodialysis: Results of a Randomized Phase 2b Study. Circulation. Published 11 November 2019. doi:10.1161/circulationaha.119.044195

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