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Kidney Week

Abstract: TH-PO1156

Targeting Vascular Calcification in Calciphylaxis

Session Information

  • Late-Breaking Posters
    November 02, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
    Abstract Time: 10:00 AM - 12:00 PM

Category: Bone and Mineral Metabolism

  • 502 Bone and Mineral Metabolism: Clinical

Author

  • Nigwekar, Sagar U., Mass General Brigham Inc, Boston, Massachusetts, United States

Group or Team Name

  • On behalf of VitK-CUA trial investigators
Background

Despite recent advances in the understanding of calcification inhibitors, there is no approved therapy for calciphylaxis-- a serious vascular calcification disorder that predominantly affects patients with end stage kidney disease. We sought to examine the link between pharmacotherapeutic strategies targeting vascular calcification (vitamin K, intravenous sodium thiosulfate, intralesional sodium thiosulfate, bisphosphonate, and calcimimetiic) and clinical outcomes in calciphylaxis.

Methods

We analysed data from phase 2, double-blind, placebo-controlled trial of phytonadione (vitamin K1) that enrolled adult hemodialysis patients with calciphylaxis (ClinicalTrials.gov #, NCT02278692). Eligible patients (n=26) underwent randomization to receive either oral phytonadione 10 mg (n=13) or placebo (n=13) thrice weekly for 12 weeks. Selection of other vascular calcification treatments was up to the clinician’s discretion. We examined the associations between calcification treatments and clinical outcomes (pain intensity and skin lesion total surface area analysed as comparison between the end of trial and baseline). We explored whether the effect of phytonadione is influenced by the administration of co-treatments.

Results

Improvements in pain intensity and total lesion surface area were seen among 58% and 46% of patients, respectively. Phytonadione therapy led to improvements in pain intensity (92% phytonadione vs. 8% placebo, p<0.001) and total lesion surface area (69% phytonadione vs. 31% placebo, p=0.018) in higher number of patients compared with placebo. Intralesional sodium thiosulfate was administered to 39% of trial participants, 50% of trial participants were treated with cinacalcet, all received intravenous thiosulfate, and none received etelcalcetide or bisphosphonate. Intralesional sodium thiosulfate or cinacalcet by themselves were not associated with improvements in clinical outcomes. The effect of phytonadione was seen even among patients not treated with Intralesional sodium thiosulfate or cinacalcet.

Conclusion

Early data demonstrate that the effect of phytonadione is seen even in the absence of application of cinacalcet and intralesional sodium thiosulfate. Whether the effect differs according to the applicaiton of intravenous sodium thisulfate needs further investigation.

Funding

  • Private Foundation Support