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Phase 3 Study of SNF472 for Calciphylaxis (Calciphyx)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04195906
Recruitment Status : Active, not recruiting
First Posted : December 12, 2019
Last Update Posted : August 30, 2022
Sponsor:
Information provided by (Responsible Party):
Sanifit Therapeutics S. A.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Calciphylaxis Calcific Uremic Arteriolopathy Drug: Experimental: SNF472 Drug: Placebo Comparator: Placebo Drug: Experimatenl SNF472 (Open-label) Phase 3

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.. .
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 12, 2020
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SNF472 (Double-Blind Period)
Dose: 7 mg/kg SNF472 diluted in 100 mL physiological saline.
 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
Placebo Comparator: Placebo (Double-Blind Period)
Matching placebo (saline) diluted in 100 mL physiological saline.
 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
Other Name: Saline
Experimental: SNF472 (Open-Label)
Dose: 7 mg/kg SNF472 diluted in 100 mL physiological saline.
 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


Outcome Measures
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Primary Outcome Measures :
  1. Change in the BWAT-CUA score for the primary lesion [ Time Frame: Basline to week 12 ]
    The Bates Jensen Wound Assessment Tool (BWAT) CUA score ranges from a minimum score of 8 (best) to a maximum score of 40 (worst)

  2. Change in Pain VAS score [ Time Frame: Baseline to Week 12 ]
    The Pain Visual Analog Scale (VAS) score ranges from a minimum score of 0 (no pain) to 100 (worst possible pain)


Secondary Outcome Measures :
  1. Change in the Wound-QoL score [ Time Frame: Basline to Week 12 ]
    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.

  2. Change in the BWAT total score for the primary lesion [ Time Frame: Baseline to Week 12 ]
    The Bates Jensen Wound Assessment Tool (BWAT) score ranges from a minimum score of 9 (best) to a maximum score of 65 (worst) score

  3. Qualitative wound image evaluation for the primary lesion [ Time Frame: Baseline to Week 12 ]
  4. Rate of change in opioid use as measured in morphine milligram equivalents (MME) [ Time Frame: Baseline to Week 12 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04195906


Locations
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Sponsors and Collaborators
Sanifit Therapeutics S. A.
Investigators
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Study Director: Alex Gold, MD Sanifit Therapeutics
More Information
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Responsible Party: Sanifit Therapeutics S. A.
ClinicalTrials.gov Identifier: NCT04195906    
Other Study ID Numbers: SNFCT2017-06
First Posted: December 12, 2019    Key Record Dates
Last Update Posted: August 30, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sanifit Therapeutics S. A.:
Calciphylaxis
Calcific Uremic Arteriolopathy
Wound
ESRD
Additional relevant MeSH terms:
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Calciphylaxis
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases