Observational Follow-up to ST-001 Calciphylaxis Pain Treatment With Intravenous Sodium Thiosulfate

Study Overview
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Brief Summary
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This is an 8-week observational follow-up study of patients who participated in the ST-001 CALISTA study (A Phase 3, Intravenous Sodium Thiosulfate for Acute Calciphylaxis Treatment: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial).

Detailed Description
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This is an 8-week observational follow-up study of patients who participated in the ST-001 CALISTA study. In this ST-003 (OF-CALISTA) study, the occurrence of delayed adverse events, standard of care treatments for calciphylaxis (medications [including Sodium Thiosulfate Injection and pain medication], wound debridement, amputation, hyperbaric oxygen therapy, and surgical parathyroidectomy), and calciphylaxis-related complications (new or worsening skin lesions, ulceration, infection, sepsis and hospitalizations) will be recorded during an 8-week observation period following patient participation in the ST-001 CALISTA study (A Phase 3, Intravenous Sodium Thiosulfate for Acute Calciphylaxis Treatment: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial).

Official Title
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Observational Follow-up to ST-001 Calciphylaxis Pain Treatment With Intravenous Sodium Thiosulfate

Conditions
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Calciphylaxis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previously enrolled as a patient in ST-001 CALISTA study Willing to provide written informed consent Willing and able to adhere to all study-related procedures Willing to authorize release of medical records Willing to authorize collection of medical data from health care providers Provide email, home address and phone number where he/she can be reached Exclusion Criteria: • Patient did not participate in ST-001 CALISTA study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ST-003 Observational<br>Calciphylaxis patients who participated in the ST-001 CALISTA | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observation of delayed adverse events, standard of care treatments for calciphylaxis following participation in ST-001 | Record the occurrence of delayed adverse events, standard of care treatments for calciphylaxis(medications [including Sodium Thiosulfate Injection and pain medication], wound debridement, amputation, hyperbaric oxygen therapy, and surgical parathyroidectomy), and calciphylaxis-related complications (new or worsening skin lesions, ulceration, infection, sepsis and hospitalizations) following participation in ST-001 | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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calciphylaxis, calcific uremic arteriolopathy,, calcium metabolism disorders, metabolic diseases, sodium thiosulfate