Phase 3 Study of SNF472 for Calciphylaxis

NCT04195906 ↗

Phase 3 Completed 71 enrolled Sanifit Therapeutics S. A.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objectives are to assess the efficacy, safety, and tolerability of SNF472 compared to placebo when added to background care for the treatment of calciphylaxis (CUA).

Timeline

Start: 2020-02-12
Primary completion: 2022-10-24
Completion: 2022-10-24

Outcome

Missed primary endpoint

registry analysis (superiority test); SNF472 vs Placebo; p = 0.877; Least Squares Mean Difference 0.27 (96% CI -2.46 to 3.00); MMRM NCT04195906 ↗

registry analysis (superiority test); SNF472 vs Placebo; p = 0.146; Least Squares Mean Difference 11.49 (96% CI -4.80 to 27.78); MMRM NCT04195906 ↗

Publications

Sinha S, Nigwekar SU, Brandenburg V, Gould LJ, Serena TE, Moe SM, Aronoff GR, Chatoth DK, Hymes JL, Carroll KJ, Alperovich G, Keller LH, Perello J, Gold A, Chertow GM. Hexasodium fytate for the treatment of calciphylaxis: a randomised, double-blind, phase 3, placebo-controlled trial with an open-label extension. EClinicalMedicine. 2024 Aug 16;75:102784. doi: 10.1016/j.eclinm.2024.102784. eCollection 2024 Sep.
Krishnasamy R, Jardine MJ; BEAT-Calci Trialists. Adaptive Designs for Clinical Trials in Nephrology. J Am Soc Nephrol. 2025 Jan 1;36(1):147-149. doi: 10.1681/ASN.0000000000000497. Epub 2024 Aug 26. No abstract available.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	HEXASODIUM PHYTATE	Small molecule	7 mg/kg	Intravenous