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Phase 3 Study of SNF472 for Calciphylaxis (Calciphyx)

Primary Purpose

Calciphylaxis, Calcific Uremic Arteriolopathy

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Experimental: SNF472
Placebo Comparator: Placebo
Experimatenl SNF472 (Open-label)
Sponsored by
Sanifit Therapeutics S. A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Calciphylaxis focused on measuring Calciphylaxis, Calcific Uremic Arteriolopathy, Wound, ESRD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Female or male subjects, 18 years of age or older
  • Receiving maintenance HD in a clinical setting for at least 2 weeks prior to screening
  • 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.
  • Willing and able to understand and sign the informed consent form and willing to comply with all aspects of the protocol

Exclusion Criteria:

  • History of treatment with bisphosphonates within 3 months of baseline
  • Severely ill subjects without a reasonable expectation of survival for at least 6 months
  • Subjects with a scheduled parathyroidectomy during the study period
  • Expectation for kidney transplant within the next 6 months based on Investigator assessment or identification of a known living donor
  • Pregnant or trying to become pregnant, currently breastfeeding, or of childbearing potential (including perimenopausal women who have had a menstrual period within one year) and not willing to comply with protocol required contraception criteria
  • Significant noncompliance with dialysis
  • History of active malignancy within the last year with the exception of localized basal cell or squamous cell carcinoma
  • Clinically significant illness other than CUA within 30 days
  • Participation in an investigational study and receipt of an investigational drug or investigational use of a licensed drug within 30 days prior to screening.
  • History or presence of active alcoholism or drug abuse as determined by the Investigator within 6 months
  • Mental impairment, current significant psychiatric disease, or other conditions or circumstances that would make the subject unlikely to complete the study or comply with the study procedures.
  • Subjects whose CUA lesions exhibit significant improvement, in the opinion of the Investigator, between the first and second screening visit

Sites / Locations

  • AKDHC Medical Research Services
  • California Institute of Renal Research
  • California Institute of Renal Research
  • Kidney Disease Medical Group
  • DaVita Clinical Research
  • Apex Research of Riverside
  • Fresenius Kidney Care
  • North America Research Institute
  • Amicis Research Center
  • Colorado Kidney Care
  • Boca Nephrology, PA
  • DaVita Clinical Research
  • Novel Outcomes Research
  • DaVita Clinical Research
  • Fresenius Kidney Care
  • Massachusetts General Hospital
  • Michigan Kidney Consultants
  • DaVita Clinical Research
  • DaVita Clinical Research
  • Fresenius Kidney Care
  • DaVita Clinical Research
  • DaVita Clinical Research
  • Fresenius Kidney Care
  • DaVita Clinical Research
  • DaVita Clinical Research
  • Fresenius Kidney Care
  • Piedmont Dialysis Center
  • Hypertension Nephrology Consultants, Inc
  • Fresenius Kidney Care
  • DaVita Clinical Research
  • Fresenius Kidney Care
  • Knoxville Kidney Center
  • DaVita Clinical Research
  • Clinical Advancement Center
  • DaVita Clinical Research
  • DaVita Clinical Research
  • Fresenius Kidney Care
  • DaVita Clinical Research
  • Clinques Universitaries de Bruxelles Hopital
  • UZ Leuven
  • AZ Delta
  • Nephrologischen Zentrum Villingen-Schwenningen
  • Charite Universitaetsmedizin Berlin - Campus Charite Mitte
  • DaVita Deutschland AG
  • Centrum Dializ Fresenius, Ośrodek Dializ nr 10 w Bydgoszczy 85-826
  • Centrum Dializ Fresenius, Ośrodek Dializ nr 18 w Krakowie..
  • DaVita Sp. z o.o., Stacja Dializ w Miechowie
  • Centrum Dializ Fresenius Ośrodek Dializ nr 32 w Radomiu 26-617 .
  • Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego w Lodzi Stacja Dializ,
  • Fundacio Puigvert
  • University of Barcelona Hospital Clinic
  • Hospital Universitario Reina Sofia
  • Royal Devon and Exeter Hospital (Wonford)
  • Salford Royal NHS Foundation Trust
  • Leicester General Hospital
  • Queen Elizabeth University Hospital Campus
  • Queen Elizabeth Hospital
  • Kings College Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

SNF472 (Double-Blind Period)

Placebo (Double-Blind Period)

SNF472 (Open-Label)

Arm Description

Dose: 7 mg/kg SNF472 diluted in 100 mL physiological saline.

Matching placebo (saline) diluted in 100 mL physiological saline.

Dose: 7 mg/kg SNF472 diluted in 100 mL physiological saline.

Outcomes

Primary Outcome Measures

Change in the BWAT-CUA score for the primary lesion
The Bates Jensen Wound Assessment Tool (BWAT) CUA score ranges from a minimum score of 8 (best) to a maximum score of 40 (worst)
Change in Pain VAS score
The Pain Visual Analog Scale (VAS) score ranges from a minimum score of 0 (no pain) to 100 (worst possible pain)

Secondary Outcome Measures

Change in the Wound-QoL score
The Wound Quality of Life scale is a validated self-assessment tool that has been shown to be feasible for assessing health-related quality of life in patients with chronic wounds. Lower scores are associated with a better quality of life as reported by the patient.
Change in the BWAT total score for the primary lesion
The Bates Jensen Wound Assessment Tool (BWAT) score ranges from a minimum score of 9 (best) to a maximum score of 65 (worst) score
Qualitative wound image evaluation for the primary lesion
Rate of change in opioid use as measured in morphine milligram equivalents (MME)

Full Information

First Posted
December 10, 2019
Last Updated
August 29, 2022
Sponsor
Sanifit Therapeutics S. A.
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1. Study Identification

Unique Protocol Identification Number
NCT04195906
Brief Title
Phase 3 Study of SNF472 for Calciphylaxis
Acronym
Calciphyx
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 12, 2020 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanifit Therapeutics S. A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calciphylaxis, Calcific Uremic Arteriolopathy
Keywords
Calciphylaxis, Calcific Uremic Arteriolopathy, Wound, ESRD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SNF472 (Double-Blind Period)
Arm Type
Experimental
Arm Description
Dose: 7 mg/kg SNF472 diluted in 100 mL physiological saline.
Arm Title
Placebo (Double-Blind Period)
Arm Type
Placebo Comparator
Arm Description
Matching placebo (saline) diluted in 100 mL physiological saline.
Arm Title
SNF472 (Open-Label)
Arm Type
Experimental
Arm Description
Dose: 7 mg/kg SNF472 diluted in 100 mL physiological saline.
Intervention Type
Drug
Intervention Name(s)
Experimental: SNF472
Intervention Description
Administered 3 times weekly by intravenous infusion through the hemodialysis machine in conjunction with the subject's hemodialysis sessions for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator: Placebo
Other Intervention Name(s)
Saline
Intervention Description
Administered 3 times weekly by intravenous infusion through the hemodialysis machine in conjunction with the subject's hemodialysis sessions fo 12 weeks
Intervention Type
Drug
Intervention Name(s)
Experimatenl SNF472 (Open-label)
Intervention Description
Administered 3 times weekly by intravenous infusion through the hemodialysis machine in conjunction with the subject's hemodialysis sessions for 12 weeks
Primary Outcome Measure Information:
Title
Change in the BWAT-CUA score for the primary lesion
Description
The Bates Jensen Wound Assessment Tool (BWAT) CUA score ranges from a minimum score of 8 (best) to a maximum score of 40 (worst)
Time Frame
Basline to week 12
Title
Change in Pain VAS score
Description
The Pain Visual Analog Scale (VAS) score ranges from a minimum score of 0 (no pain) to 100 (worst possible pain)
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Change in the Wound-QoL score
Description
The Wound Quality of Life scale is a validated self-assessment tool that has been shown to be feasible for assessing health-related quality of life in patients with chronic wounds. Lower scores are associated with a better quality of life as reported by the patient.
Time Frame
Basline to Week 12
Title
Change in the BWAT total score for the primary lesion
Description
The Bates Jensen Wound Assessment Tool (BWAT) score ranges from a minimum score of 9 (best) to a maximum score of 65 (worst) score
Time Frame
Baseline to Week 12
Title
Qualitative wound image evaluation for the primary lesion
Time Frame
Baseline to Week 12
Title
Rate of change in opioid use as measured in morphine milligram equivalents (MME)
Time Frame
Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female or male subjects, 18 years of age or older Receiving maintenance HD in a clinical setting for at least 2 weeks prior to screening 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. Willing and able to understand and sign the informed consent form and willing to comply with all aspects of the protocol Exclusion Criteria: History of treatment with bisphosphonates within 3 months of baseline Severely ill subjects without a reasonable expectation of survival for at least 6 months Subjects with a scheduled parathyroidectomy during the study period Expectation for kidney transplant within the next 6 months based on Investigator assessment or identification of a known living donor Pregnant or trying to become pregnant, currently breastfeeding, or of childbearing potential (including perimenopausal women who have had a menstrual period within one year) and not willing to comply with protocol required contraception criteria Significant noncompliance with dialysis History of active malignancy within the last year with the exception of localized basal cell or squamous cell carcinoma Clinically significant illness other than CUA within 30 days Participation in an investigational study and receipt of an investigational drug or investigational use of a licensed drug within 30 days prior to screening. History or presence of active alcoholism or drug abuse as determined by the Investigator within 6 months Mental impairment, current significant psychiatric disease, or other conditions or circumstances that would make the subject unlikely to complete the study or comply with the study procedures. Subjects whose CUA lesions exhibit significant improvement, in the opinion of the Investigator, between the first and second screening visit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Gold, MD
Organizational Affiliation
Sanifit Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
AKDHC Medical Research Services
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85035
Country
United States
Facility Name
California Institute of Renal Research
City
El Centro
State/Province
California
ZIP/Postal Code
92243
Country
United States
Facility Name
California Institute of Renal Research
City
Escondido
State/Province
California
ZIP/Postal Code
92027
Country
United States
Facility Name
Kidney Disease Medical Group
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
DaVita Clinical Research
City
Lynwood
State/Province
California
ZIP/Postal Code
90260
Country
United States
Facility Name
Apex Research of Riverside
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
Facility Name
Fresenius Kidney Care
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States
Facility Name
North America Research Institute
City
San Dimas
State/Province
California
ZIP/Postal Code
91773
Country
United States
Facility Name
Amicis Research Center
City
Vacaville
State/Province
California
ZIP/Postal Code
95687
Country
United States
Facility Name
Colorado Kidney Care
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Boca Nephrology, PA
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States
Facility Name
DaVita Clinical Research
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Novel Outcomes Research
City
Spring Hill
State/Province
Florida
ZIP/Postal Code
34667
Country
United States
Facility Name
DaVita Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Fresenius Kidney Care
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Michigan Kidney Consultants
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Facility Name
DaVita Clinical Research
City
Roseville
State/Province
Michigan
ZIP/Postal Code
48066
Country
United States
Facility Name
DaVita Clinical Research
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Fresenius Kidney Care
City
Brookhaven
State/Province
Mississippi
ZIP/Postal Code
39601
Country
United States
Facility Name
DaVita Clinical Research
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
DaVita Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Fresenius Kidney Care
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Facility Name
DaVita Clinical Research
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
DaVita Clinical Research
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Fresenius Kidney Care
City
Durham
State/Province
North Carolina
ZIP/Postal Code
22704
Country
United States
Facility Name
Piedmont Dialysis Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27101
Country
United States
Facility Name
Hypertension Nephrology Consultants, Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Fresenius Kidney Care
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
DaVita Clinical Research
City
Chester
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Facility Name
Fresenius Kidney Care
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Knoxville Kidney Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923
Country
United States
Facility Name
DaVita Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Clinical Advancement Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Facility Name
DaVita Clinical Research
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
DaVita Clinical Research
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Fresenius Kidney Care
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
DaVita Clinical Research
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Clinques Universitaries de Bruxelles Hopital
City
Bruxelles
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
Country
Belgium
Facility Name
AZ Delta
City
Roeselare
Country
Belgium
Facility Name
Nephrologischen Zentrum Villingen-Schwenningen
City
Villingen-Schwenningen
State/Province
Baden Wuerttemberg
Country
Germany
Facility Name
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
City
Berlin
Country
Germany
Facility Name
DaVita Deutschland AG
City
Düsseldorf
Country
Germany
Facility Name
Centrum Dializ Fresenius, Ośrodek Dializ nr 10 w Bydgoszczy 85-826
City
Bydgoszcz
Country
Poland
Facility Name
Centrum Dializ Fresenius, Ośrodek Dializ nr 18 w Krakowie..
City
Krakow
Country
Poland
Facility Name
DaVita Sp. z o.o., Stacja Dializ w Miechowie
City
Miechów
Country
Poland
Facility Name
Centrum Dializ Fresenius Ośrodek Dializ nr 32 w Radomiu 26-617 .
City
Radom
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego w Lodzi Stacja Dializ,
City
Łódź
Country
Poland
Facility Name
Fundacio Puigvert
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
University of Barcelona Hospital Clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Reina Sofia
City
Córdoba
Country
Spain
Facility Name
Royal Devon and Exeter Hospital (Wonford)
City
Exeter
State/Province
Devon
Country
United Kingdom
Facility Name
Salford Royal NHS Foundation Trust
City
Salford
State/Province
Greater Manchester
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Leicester General Hospital
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
le5 4pw
Country
United Kingdom
Facility Name
Queen Elizabeth University Hospital Campus
City
Glasgow
State/Province
Strathclyde
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
Birmingham
State/Province
West Midlands
Country
United Kingdom
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SE59RS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Phase 3 Study of SNF472 for Calciphylaxis

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