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A Phase 3 Clinical Trial of Intravenous Sodium Thiosulfate in Acute Calciphylaxis Patients

NCT03150420 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2020-05-19

No results posted yet for this study

Summary

This multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of intravenous Sodium Thiosulfate Injection for treatment of acute calciphylaxis-associated pain in chronic hemodialysis patients.

Conditions

  • Calciphylaxis

Interventions

DRUG

Sodium Thiosulfate

Intravenous Sodium Thiosulfate Injection (25 grams sodium thiosulfate) to be administered each hemodialysis session (3 times weekly) for 3 weeks

DRUG

Placebo-Normal Saline

Placebo: to be administered each hemodialysis session (3 times weekly) for 3 weeks

Sponsors & Collaborators

  • Hope Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Craig Sherman, MD · Hope Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-24
Primary Completion
2020-04-15
Completion
2020-04-15
FDA Drug
Yes

Countries

  • United States
  • Canada
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03150420 on ClinicalTrials.gov