REDUCTION OF CALCIPHYLAXIS-RELATED INFECTIONS WITH HEXASODIUM FYTATE TREATMENT IN A RANDOMIZED, DOUBLE-BLIND, PHASE 3, PLACEBO-CONTROLLED TRIAL

Introduction:

CALCIPHYX was an international, phase 3, randomized, double-blind, placebo-controlled clinical trial that investigated hexasodium fytate (SNF472), an inhibitor of vascular calcification, for the treatment of calciphylaxis. Infection of calciphylaxis skin lesions is a serious complication and effective strategies to reduce the rate of calciphylaxis-related infection are lacking. In this post-hoc analysis, we compare rates of calciphylaxis-related infections between groups as randomized through Week 12.

Methods:

Adults with an ulcerated calciphylaxis lesion and pain visual analog scale score ≥50/100 received double-blind hexasodium fytate 7 mg/kg or placebo intravenously during maintenance hemodialysis to Week 12 and open label hexasodium fytate to Week 24 with an end of study (EOS) visit at Week 28. Exploratory post-hoc analyses of calciphylaxis-related infection (adverse events in the Infections and Infestations system organ class) included time to first event (Kaplan-Meier, Greenwood variance with hazard ratio and confidence interval [CI] by bootstrapping Cox proportional regression and Exact Wilcoxon p-value) and rate ratios (negative binomial regression). P-values were nominal.

Results:

Any calciphylaxis-related infection was reported for 1/37 patients (1 event total) in the hexasodium fytate group and 7/34 patients (10 events total) in the placebo group (Figure). The hazard ratio for hexasodium fytate vs placebo at Weeks 12 and 24 was 0.11 (95% CI: 0.00-0.64; p=0.026). Exposure-adjusted rate ratios for hexasodium fytate vs placebo were: Week 12, 0.086 (95% CI: 0.021-0.346; p<0.001); Week 24, 0.061 (95% CI: 0.015-0.250; p<0.001); and EOS, 0.057 (95% CI: 0.014-0.238; p<0.001).

Conclusions:

In this exploratory analysis, hexasodium fytate treatment during hemodialysis reduced the incidence of first and multiple calciphylaxis-related infections.

This abstract was also submitted for the American Society of Nephrology Kidney Week 2024 congress.

I have potential conflict of interest to disclose.
Commercial Support - Study funded by Sanifit, a CSL Vifor company

I did not use generative AI and AI-assisted technologies in the writing process.