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Completed

NCT Number: NCT02790073

Phase 2 Study With SNF472 in Calciphylaxis Patients

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).

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Key information

Conditions

Calciphylaxis Calcific Uremic Arteriolopathy Calcinosis Calcium Metabolism Disorders Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rare Diseases Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Salford Royal Hospital, Salford, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SNF472

Drug

SNF472 for calciphylaxis

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sanifit Therapeutics S. A.

Other

Registry information

Official study title

Phase 2 Open Label Single Arm Repeat Dose Study to Assess the Effect of SNF472 on Wound Healing in Uraemic Calciphylaxis Patients

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 3, 2016
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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