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Phase 2 Study With SNF472 in Calciphylaxis Patients

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ClinicalTrials.gov Identifier: NCT02790073
Recruitment Status : Completed
First Posted : June 3, 2016
Results First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Laboratoris Sanifit

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).

Condition or disease Intervention/treatment Phase
Calciphylaxis Calcific Uremic Arteriolopathy Drug: SNF472 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Open Label Single Arm Repeat Dose Study to Assess the Effect of SNF472 on Wound Healing in Uraemic Calciphylaxis Patients
Actual Study Start Date : May 2016
Actual Primary Completion Date : November 15, 2017
Actual Study Completion Date : November 15, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
SNF472
SNF472 for calciphylaxis
Drug: SNF472
SNF472 for calciphylaxis




Primary Outcome Measures :
  1. Wound Healing [ Time Frame: 12 weeks ]

    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 :
  1. Wound Pain [ Time Frame: 12 weeks ]

    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).


  2. Wound-QoL Global Score [ Time Frame: 12 weeks ]

    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.




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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:

  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

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): NCT02790073


Locations
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United States, Massachusetts
Fresenius Medical Services
Waltham, Massachusetts, United States, 02451
United States, Minnesota
Davita Clinical Research
Minneapolis, Minnesota, United States, 55404
United Kingdom
Salford Royal Hospital
Salford, United Kingdom
Sponsors and Collaborators
Laboratoris Sanifit
Investigators
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Principal Investigator: Vincent Brandenburg RWTH Aachen University
  Study Documents (Full-Text)

Documents provided by Laboratoris Sanifit:
Study Protocol  [PDF] April 11, 2017
Statistical Analysis Plan  [PDF] January 31, 2018


Additional Information:
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Responsible Party: Laboratoris Sanifit
ClinicalTrials.gov Identifier: NCT02790073     History of Changes
Other Study ID Numbers: SNFCT2015_04
First Posted: June 3, 2016    Key Record Dates
Results First Posted: August 28, 2019
Last Update Posted: August 28, 2019
Last Verified: August 2019
Keywords provided by Laboratoris Sanifit:
Calciphylaxis
Calcific Uremic Arteriolopathy
Dialysis
End Stage Renal Disease
Rare disease (ORPHA280062)
Calcification
Calcium Metabolism Disorders
Calcinosis
Metabolic Diseases
Additional relevant MeSH terms:
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Calciphylaxis
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases