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Experimental: SNF472 for Calciphylaxis (Calciphyx Trial)

Phase 3
Waitlist Available
Research Sponsored by Sanifit Therapeutics S. A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 12
Awards & highlights
Pivotal Trial

Summary

This trial will compare the effectiveness of SNF472 to a placebo in treating calciphylaxis (CUA).

Eligible Conditions
  • Calciphylaxis
  • Calcific Uremic Arteriolopathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Absolute Change in Pain Visual Analog Score
Absolute Change in the BWAT - CUA Score for the Primary Lesion
Secondary study objectives
Absolute Change in the BWAT Total Score for the Primary Lesion
Absolute Change in the Wound-Quality of Life Score
Qualitative Wound Image Evaluation for the Primary Lesion
+1 more

Side effects data

From 2022 Phase 3 trial • 71 Patients • NCT04195906
21%
Calciphylaxis
13%
Arthralgia
13%
Vomiting
11%
Pain in extremity
8%
Headache
8%
Fall
5%
Nausea
5%
Atrial fibrillation
5%
Hypervolemia
5%
Anaemia
5%
Decreased appetite
5%
Arteriovenous fistula site haemorrhage
5%
Hypokalaemia
5%
Muscular weakness
5%
Hypervolaemia
5%
Diarrhoea
5%
Back pain
5%
Cellulitis
5%
Pyrexia
5%
Arteriovenous fistula site complication
5%
Pain
3%
Cerebrovascular accident
3%
Spinal fracture
3%
Sepsis
3%
Staphylococcal bacteraemia
3%
Lactic acidosis
3%
Pneumonia
3%
Angina pectoris
3%
Gangrene
3%
Tooth infection
3%
Encephalopathy
3%
Arteriovenous graft site haemorrhage
3%
Hyperkalaemia
3%
COVID-19
3%
Cardiac failure acute
3%
Mental status changes
3%
Cholelithiasis
3%
Asthenia
3%
Atrial flutter
3%
Cardiac arrest
3%
Cardiac failure
3%
Accidental overdose
3%
Cardiac failure congestive
3%
Arteriovenous fistula site infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
SNF472 - Safety Analysis Population (Part 1)
Placebo - Safety Analysis Population (Part 1)
SNF472 Open Label - Safety Analysis Population (Part 2)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Experimatenl SNF472 (Open-label)
2020
Completed Phase 3
~80
Experimental: SNF472
2020
Completed Phase 3
~80

Find a Location

Who is running the clinical trial?

Sanifit Therapeutics S. A.Lead Sponsor
3 Previous Clinical Trials
324 Total Patients Enrolled
1 Trials studying Calciphylaxis
14 Patients Enrolled for Calciphylaxis
Alex Gold, MDStudy DirectorSanifit Therapeutics
3 Previous Clinical Trials
4,754 Total Patients Enrolled
~12 spots leftby Nov 2025
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