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Phase 3 Study of SNF472 for Calciphylaxis

NCT04195906 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2024-02-20

Study results available
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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).

Conditions

  • Calciphylaxis
  • Calcific Uremic Arteriolopathy

Interventions

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

Sponsors & Collaborators

  • Sanifit Therapeutics S. A.

    lead OTHER

Principal Investigators

  • Alex Gold, MD · Sanifit Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-12
Primary Completion
2022-10-24
Completion
2022-10-24
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Germany
  • Poland
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04195906 on ClinicalTrials.gov