Table 1.

Study eligibility criteria

Inclusion criteria
≥18 years of age
Receiving maintenance haemodialysis in a clinical setting (i.e. excluding home haemodialysis) for at least 2 weeks prior to screening
Clinical diagnosis of calciphylaxis by the Investigator including ≥1 calciphylaxis lesion with ulceration of the epithelial surface. A central wound rating group will review wound images to confirm the primary lesion is due to calciphylaxis
Calciphylaxis wound-related pain shown by a pain VAS ≥50 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
Patients whose primary lesion is due to causes other than calciphylaxis
History of treatment with bisphosphonates within 3 months of baseline (Week 1, Day 1)
Severely ill patients without a reasonable expectation of survival for at least 6 months based on the assessment of the Investigator
Patients 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 1 year) and not willing to either completely avoid sexual intercourse with a person of the opposite sex or use a highly effective method of birth control from screening through at least 30 days after last dose of study drug
Significant non-compliance with dialysis treatment evidenced by repeated missed dialysis sessions (including if due to hospitalizations where dialysis treatment is unavailable) or significant non-compliance with medication regimen, in the judgement of the Investigator
Any history of active malignancy within the last year (history of localized basal cell or squamous cell carcinoma that has been excised/appropriately treated or a fully excised malignant lesion with a low probability of recurrence will not be considered exclusionary)
Clinically significant illness other than calciphylaxis within 30 days prior to screening that, in the judgment of the Investigator, could interfere with interpretation of study results, impair compliance with study procedures or impact the safety of the patient (e.g. unstable angina, unstable heart failure, stroke, uncontrolled hypertension or other illness requiring hospitalization)
Participation in an investigational study and receipt of an investigational drug or investigational use of a licensed drug (with the exception of intravenous STS) within 30 days prior to screening. If participating in an investigational study of intravenous STS, all visits of that study must be completed prior to screening for this study. Note: off-label use of intravenous STS outside of an investigational study is not restricted
Past or current participation in another clinical study with SNF472
History or presence of active alcoholism or drug abuse as determined by the Investigator within 6 months before screening or concurrent social conditions that, in the opinion of the Investigator, would potentially interfere with the patient’s study compliance
Mental impairment or history of or current significant psychiatric disease that, in the opinion of the Investigator, may impair ability to provide informed consent or impact compliance with study procedures
Any other condition or circumstance that, in the opinion of the Investigator, may make the patient unlikely to complete the study or comply with study procedures and requirements or may pose a risk to the patient's safety and well-being
Patients whose calciphylaxis lesions exhibit significant improvement, in the opinion of the Investigator, between the first and second screening visit