Slowing Progression of Cardiovascular Calcification With SNF472 in Patients on Hemodialysis: Results of a Randomized Phase 2b Study
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
| Outcome | Placebo | P value |
|---|---|---|
| Aortic valve calcium volume score progressionSNF472 vs Placebo | 98% (95% CI 77–123) | P < 0.001 |
| Thoracic aorta calcium volume score progressionSNF472 vs Placebo | 28% (95% CI 19–38) | P = 0.40 |
| Death | 6% |
- 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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