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 |
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).
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).
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
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