Chertow GM, Raggi P, Bellasi A, et al.
SNF472 Consistently Slows Progression of Coronary Artery Calcification
Across Subgroups of Patients on Hemodialysis
ASN Annual Meeting 2020 -- Digital Meeting
J Am Soc Nephrol
(Oct) 31:6A 2020

BACKGROUND
In the CaLIPSO study, SNF472 significantly attenuated
progression of coronary artery calcium (CAC) volume score compared with
placebo. This pre-specified analysis examined CAC progression in key
subgroups.
METHODS
Patients were randomized to SNF472 300 mg
(n=92), SNF472 600 mg (n=91) or placebo (n=91) infused 3x/week during
hemodialysis (HD) for 52 weeks on top of standard care therapy determined by
each investigator. We examined change in log CAC volume score from baseline
to week 52 in the combined SNF472 dose groups vs placebo for subgroups of
age, sex, diabetes, dialysis vintage, arteriosclerotic cardiovascular disease
(ASCVD), use of non-Ca phosphate binders, Ca-based phosphate binders,
calcimimetics, activated vitamin D, warfarin, or statins in the modified ITT
population (mITT, defined as subjects who received at least one dose of study
drug and had an evaluable post-baseline CT
scan).
RESULTS
Baseline characteristics were similar across
treatment groups: mean age was 64 y, 39% were female; 62% had diabetes, and
41% had prior ASCVD. Median HD vintage was 42 mo; 33% received HD for ≥5
years. Concomitant medications at baseline were: 62% non-Ca phosphate
binders, 28% Ca-based phosphate binders, 31% calcimimetics, 51% activated vit
D, 8% warfarin, and 64% statins. In the overall mITT, CAC volume progression
was 11% in the combined SNF472 groups vs 20% in placebo (p=0.016). Treatment
differences for CAC volume progression were similar across subgroups
(Figure). All interaction p-values were non-significant and comparisons
favored SNF472 vs placebo in each subgroup.
CONCLUSION
SNF472
treatment for 52 weeks attenuated CAC progression compared with placebo in
all subgroups.


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