Observational Follow-up to ST-001 Calciphylaxis Pain Treatment With Intravenous Sodium Thiosulfate (OF-CALISTA)

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).

Study Overview

• Status: Terminated
• Conditions: Calciphylaxis

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).

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • New York
    • Albany, New York, United States, 12208
      • Veterans Administration Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Those calciphylaxis patients that previously 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).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
ST-003 Observational; Calciphylaxis patients who participated in the ST-001 CALISTA

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hope Pharmaceuticals
• Investigators: Study Director: Craig Sherman, MD, Hope Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2017
• Primary Completion (Actual): November 9, 2018
• Study Completion (Actual): November 9, 2018

Study Registration Dates

• First Submitted: October 20, 2017
• First Submitted That Met QC Criteria: October 20, 2017
• First Posted (Actual): October 24, 2017

Study Record Updates

• Last Update Posted (Actual): November 20, 2018
• Last Update Submitted That Met QC Criteria: November 18, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: sodium thiosulfate; metabolic diseases; calcium metabolism disorders; calciphylaxis, calcific uremic arteriolopathy,
• Additional Relevant MeSH Terms: Metabolic Diseases; Calcium Metabolism Disorders; Calcinosis; Calciphylaxis
• Other Study ID Numbers: ST-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No