NCT03150420

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

A Phase 3, Intravenous Sodium Thiosulfate for Acute Calciphylaxis Treatment: A Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Trial

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Hope Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This Phase 3, 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. Acute calciphylaxis- associated pain intensity will be the primary outcome measure.

Conditions

• Calciphylaxis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-05-24
• Primary completion: 2020-04-15
• Completion: 2020-04-15
• First posted: 2017-05-12
• Last updated: 2020-05-19

Locations

21 sites across 3 countries: United States, Canada, United Kingdom

Regulatory

• FDA-regulated drug study