Abstract: FR-OR27
Reduction of Calciphylaxis-Related Infections with Hexasodium Fytate Treatment in a Randomized, Double-Blind, Phase 3, Placebo-Controlled Trial
Session Information
- Dialysis: What's New in Techniques and Management
October 25, 2024 | Location: Room 8, Convention Center
Abstract Time: 05:50 PM - 06:00 PM
Category: Dialysis
- 801 Dialysis: Hemodialysis and Frequent Dialysis
Authors
- Sinha, Smeeta, Northern Care Alliance NHS Foundation Trust, Salford, United Kingdom
- Nigwekar, Sagar U., Massachusetts General Hospital, Boston, Massachusetts, United States
- Gould, Lisa, South Shore Hospital, Weymouth, Massachusetts, United States
- Serena, Thomas E., SerenaGroup Research Foundation, Cambridge, Massachusetts, United States
- Moe, Sharon M., Indiana University School of Medicine, Indianapolis, Indiana, United States
- Aronoff, George R., DaVita Inc, Denver, Colorado, United States
- Chatoth, Dinesh K., Fresenius Medical Care Holdings Inc, Waltham, Massachusetts, United States
- Hymes, Jeffrey L., Fresenius Medical Care Holdings Inc, Waltham, Massachusetts, United States
- Alperovich Lehrer, Gabriela, Vifor Pharma Management AG, Glattbrugg, Zurich, Switzerland
- Keller, Laurence H., Clinical Development Consultant, Ann Arbor, Michigan, United States
- Gold, Alex, Clinical Development Consultant, Incline Village, Nevada, United States
- Szecsödy, Peter, Vifor Pharma Management AG, Glattbrugg, Zurich, Switzerland
- Radewonuk, Jana, CSL Behring LLC, King of Prussia, Pennsylvania, United States
- Perelló, Joan, Vifor Pharma Management AG, Glattbrugg, Switzerland
- Chertow, Glenn M., Stanford University School of Medicine, Stanford, California, United States
Group or Team Name
- CALCIPHYX Study Investigators.
Background
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).
Conclusion
In this exploratory analysis, hexasodium fytate treatment during hemodialysis reduced the incidence of first and multiple calciphylaxis-related infections.
Figure. Time to first calciphylaxis-related infection
Funding
- Commercial Support – Sanifit, a CSL Vifor company