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



Status:Terminated
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:11/22/2018
Start Date:October 20, 2017
End Date:November 9, 2018

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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).

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).

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
We found this trial at
3
sites
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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113 Holland Avenue
Albany, New York 12208
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Albany, NY
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