Phase 2 Study With SNF472 in Calciphylaxis Patients
Condition: Calciphylaxis; Calcific Uremic Arteriolopathy
MeSH terms: Calciphylaxis
Intervention: SNF472
Intervention description: SNF472 for calciphylaxis
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Calciphylaxis; Calcific Uremic Arteriolopathy; Dialysis; End Stage Renal Disease; Rare disease (ORPHA280062); Calcification; Calcium Metabolism Disorders; Calcinosis; Metabolic Diseases

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).
    

Eligibility 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