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Phase 2 Study With SNF472 in Calciphylaxis Patients

Primary Purpose

Calciphylaxis, Calcific Uremic Arteriolopathy

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SNF472
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, Dialysis, End Stage Renal Disease, Rare disease (ORPHA280062), Calcification, Calcium Metabolism Disorders, Calcinosis, Metabolic Diseases

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients with either newly diagnosed CUA OR recurrent CUA that has been dormant with no skin lesion involvement for at least 90 days from study start (new or recurrent diagnosis must be made within 5 weeks of study start)
  2. Patients who signed the written informed consent to participate in this clinical trial (prior to any clinical trial-related procedures being performed), after reading the Patient Information Sheet and Informed Consent Form (ICF), and who had the opportunity to discuss the clinical trial with the Investigator or designee
  3. Males or females aged ≥18
  4. Patients on maintenance haemodialysis (HD)
  5. Patients with at least a minimum level of pain on Visual Analog Scale (VAS) scale or on pain-killers stronger than non-steroidal anti-inflammatory drugs (NSAIDs)
  6. Females of child-bearing potential should use a highly effective contraceptive measure throughout the study and have a negative serum pregnancy test at entry. Male patients having sexual relationship in which pregnancy can occur should take adequate contraceptive precautions (wear a condom)

Exclusion Criteria:

  1. Body weight above 150 kg
  2. BMI >35 and central(abdominal) ulcers
  3. History of bisphosphonate treatment within 12 months before entering into the study
  4. Severely ill patients without reasonable expectation of survival for > 6 months according to the treating physician
  5. Patients with scheduled parathyroidectomy during the run-in or study period
  6. Female patients who are either intending to get pregnant or are undergoing treatment to get pregnant, as well as breast-feeding females
  7. Participation in another clinical trial with an experimental drug within 90 days prior the inclusion
  8. Any psychological, emotional problems, any disorders or resultant therapy that is likely to invalidate informed consent, or limit the ability of the patient to comply with the Clinical Trial Protocol requirements
  9. Patients who, in the opinion of the Investigator, are considered unsuitable for any other reason

Sites / Locations

  • Fresenius Medical Services
  • Davita Clinical Research
  • Salford Royal Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

SNF472

Arm Description

SNF472 for calciphylaxis

Outcomes

Primary Outcome Measures

Wound Healing
Absolute change in Bates-Jensen Wound Assessment (BWAT) total score between baseline (Week 1) and Week 12 for the primary lesion (the largest one). The Bates-Jensen Wound Assessment (BWAT) is a standardized tool for quantitative assessment of wound healing that includes the 13 items listed below. Size Depth Edges Undermining or pockets Necrotic tissue type Necrotic tissue amount Exudate type Exudate amount Surrounding skin color Peripheral tissue edema Peripheral tissue induration Granulation tissue Epithelialization Each item was rated on a scale of 1 (best) to 5 (worst). The Bates-Jensen Wound Assessment (BWAT) total score is the sum of the individual items with a possible range of 13 (best) to 65 (worst).

Secondary Outcome Measures

Wound Pain
Absolute change from baseline (Week 1) and Week 12 in the Pain Visual Analogue Scale (VAS) Score. The Pain Visual Analogue Scale (VAS) Score is a horizontal line, 100 mm in length, anchored by word descriptors at each end. The subject marked the point on the line that represented his/her perception of his/her current pain status. The Pain Visual Analogue Scale (VAS) Score was determined by measuring in millimeters from the left hand end of the line (no pain) to the point that the subject marked. The Pain Visual Analogue Scale (VAS) Score range 0 (best) to 100 (Worst).
Wound-QoL Global Score
Absolute change from baseline (Week 1) and Week 12 in the Wound-QoL global score. The Wound-QoL questionnaire measures the disease-specific, health related QoL of patients with chronic wounds. It consists of 17 items on impairments that are assessed in retrospect to the preceding 7 days and rated on a 0 (best) to 4 (worse) scale with possible responses from "not at all" to "very much". The total score is the average of the 17 responses.

Full Information

First Posted
May 25, 2016
Last Updated
August 27, 2019
Sponsor
Sanifit Therapeutics S. A.
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1. Study Identification

Unique Protocol Identification Number
NCT02790073
Brief Title
Phase 2 Study With SNF472 in Calciphylaxis Patients
Official Title
Phase 2 Open Label Single Arm Repeat Dose Study to Assess the Effect of SNF472 on Wound Healing in Uraemic Calciphylaxis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
November 15, 2017 (Actual)
Study Completion Date
November 15, 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
To evaluate the effect of SNF472 on top of standard of care on promoting wound healing and other parameters of therapeutic response in haemodialysis patients with calciphylaxis (calcific uraemic arteriolopathy, CUA).

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, Dialysis, End Stage Renal Disease, Rare disease (ORPHA280062), Calcification, Calcium Metabolism Disorders, Calcinosis, Metabolic Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SNF472
Arm Type
Other
Arm Description
SNF472 for calciphylaxis
Intervention Type
Drug
Intervention Name(s)
SNF472
Intervention Description
SNF472 for calciphylaxis
Primary Outcome Measure Information:
Title
Wound Healing
Description
Absolute change in Bates-Jensen Wound Assessment (BWAT) total score between baseline (Week 1) and Week 12 for the primary lesion (the largest one). The Bates-Jensen Wound Assessment (BWAT) is a standardized tool for quantitative assessment of wound healing that includes the 13 items listed below. Size Depth Edges Undermining or pockets Necrotic tissue type Necrotic tissue amount Exudate type Exudate amount Surrounding skin color Peripheral tissue edema Peripheral tissue induration Granulation tissue Epithelialization Each item was rated on a scale of 1 (best) to 5 (worst). The Bates-Jensen Wound Assessment (BWAT) total score is the sum of the individual items with a possible range of 13 (best) to 65 (worst).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Wound Pain
Description
Absolute change from baseline (Week 1) and Week 12 in the Pain Visual Analogue Scale (VAS) Score. The Pain Visual Analogue Scale (VAS) Score is a horizontal line, 100 mm in length, anchored by word descriptors at each end. The subject marked the point on the line that represented his/her perception of his/her current pain status. The Pain Visual Analogue Scale (VAS) Score was determined by measuring in millimeters from the left hand end of the line (no pain) to the point that the subject marked. The Pain Visual Analogue Scale (VAS) Score range 0 (best) to 100 (Worst).
Time Frame
12 weeks
Title
Wound-QoL Global Score
Description
Absolute change from baseline (Week 1) and Week 12 in the Wound-QoL global score. The Wound-QoL questionnaire measures the disease-specific, health related QoL of patients with chronic wounds. It consists of 17 items on impairments that are assessed in retrospect to the preceding 7 days and rated on a 0 (best) to 4 (worse) scale with possible responses from "not at all" to "very much". The total score is the average of the 17 responses.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with either newly diagnosed CUA OR recurrent CUA that has been dormant with no skin lesion involvement for at least 90 days from study start (new or recurrent diagnosis must be made within 5 weeks of study start) Patients who signed the written informed consent to participate in this clinical trial (prior to any clinical trial-related procedures being performed), after reading the Patient Information Sheet and Informed Consent Form (ICF), and who had the opportunity to discuss the clinical trial with the Investigator or designee Males or females aged ≥18 Patients on maintenance haemodialysis (HD) Patients with at least a minimum level of pain on Visual Analog Scale (VAS) scale or on pain-killers stronger than non-steroidal anti-inflammatory drugs (NSAIDs) Females of child-bearing potential should use a highly effective contraceptive measure throughout the study and have a negative serum pregnancy test at entry. Male patients having sexual relationship in which pregnancy can occur should take adequate contraceptive precautions (wear a condom) Exclusion Criteria: Body weight above 150 kg BMI >35 and central(abdominal) ulcers History of bisphosphonate treatment within 12 months before entering into the study Severely ill patients without reasonable expectation of survival for > 6 months according to the treating physician Patients with scheduled parathyroidectomy during the run-in or study period Female patients who are either intending to get pregnant or are undergoing treatment to get pregnant, as well as breast-feeding females Participation in another clinical trial with an experimental drug within 90 days prior the inclusion Any psychological, emotional problems, any disorders or resultant therapy that is likely to invalidate informed consent, or limit the ability of the patient to comply with the Clinical Trial Protocol requirements Patients who, in the opinion of the Investigator, are considered unsuitable for any other reason
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Brandenburg
Organizational Affiliation
RWTH Aachen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fresenius Medical Services
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Facility Name
Davita Clinical Research
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Salford Royal Hospital
City
Salford
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://clinicaltrials.gov/ct2/info/fdalinks
Description
USA FDA resources
URL
http://www.sanifit.com
Description
Drug Information available for: SNF472

Learn more about this trial

Phase 2 Study With SNF472 in Calciphylaxis Patients

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