Phase 3 Study of SNF472 for Calciphylaxis
(Calciphyx Trial)
Recruiting in Palo Alto (17 mi)
+63 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Sanifit Therapeutics S. A.
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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).
Research Team
AG
Alex Gold, MD
Principal Investigator
Sanifit Therapeutics
Eligibility Criteria
Inclusion Criteria
Clinical diagnosis of CUA by the Investigator including ≥1 CUA lesion with ulceration of the epithelial surface
CUA wound-related pain shown by a Pain VAS score ≥50 out of 100
Primary lesion that can be clearly photographed for the purpose of protocol-specified wound healing assessments.
See 3 more
Treatment Details
Interventions
- Placebo (Drug)
- SNF472 (Calcimimetic)
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: SNF472 (Open-Label)Experimental Treatment1 Intervention
Dose: 7 mg/kg SNF472 diluted in 100 mL physiological saline.
Group II: SNF472 (Double-Blind Period)Experimental Treatment1 Intervention
Dose: 7 mg/kg SNF472 diluted in 100 mL physiological saline.
Group III: Placebo (Double-Blind Period)Placebo Group1 Intervention
Matching placebo (saline) diluted in 100 mL physiological saline.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
AKDHC Medical Research ServicesTucson, AZ
Fresenius Kidney CareTampa, FL
DaVita Clinical ResearchLas Vegas, NV
DaVita Clinical ResearchHouston, TX
More Trial Locations
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Who Is Running the Clinical Trial?
Sanifit Therapeutics S. A.
Lead Sponsor
Trials
4
Patients Recruited
400+