NCT04195906

Phase 3 Study of SNF472 for Calciphylaxis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SNF472 When Added to Background Care for the Treatment of Calciphylaxis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Sanifit Therapeutics S. A. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The formation and growth of calcified deposits in arterioles and other small blood vessels appears to be fundamental to the development of CUA especially in end stage renal disease patients. This phase 3 double-blind, randomized, placebo-controlled study is designed to assess the effect of SNF472 when added to background care to improve wound healing, as evaluated using Bates-Jensen Wound Assessment Tool (BWAT) scoring and pain as reported by the subject using a VAS scale. The study consists of a double-blind, randomized, placebo controlled period of 12 weeks followed by an open-label period of 12 weeks.. .

Conditions

• Calciphylaxis
• Calcific Uremic Arteriolopathy

Interventions

Type	Name	Description
DRUG	Experimental: SNF472	Administered 3 times weekly by intravenous infusion through the hemodialysis machine in conjunction with the subject's hemodialysis sessions for 12 weeks
DRUG	Placebo Comparator: Placebo	Administered 3 times weekly by intravenous infusion through the hemodialysis machine in conjunction with the subject's hemodialysis sessions fo 12 weeks
DRUG	Experimatenl SNF472 (Open-label)	Administered 3 times weekly by intravenous infusion through the hemodialysis machine in conjunction with the subject's hemodialysis sessions for 12 weeks

Timeline

• Start date: 2020-02-12
• Primary completion: 2022-10-24
• Completion: 2022-10-24
• First posted: 2019-12-12
• Last updated: 2024-02-20
• Results posted: 2024-02-20

Locations

58 sites across 6 countries: United States, Belgium, Germany, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study