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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03319914

Acronym

OF-CALISTA

Enrollment

Registered

2017-10-24

Start date

2017-10-20

Completion date

2018-11-09

Last updated

2018-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Calciphylaxis

Keywords

calciphylaxis, calcific uremic arteriolopathy,, calcium metabolism disorders, metabolic diseases, sodium thiosulfate

Brief summary

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

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Observation of delayed adverse events, standard of care treatments for calciphylaxis following participation in ST-001	8 weeks	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

Countries

United States

Outcome results