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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: Hope Pharmaceuticals

Current Primary Outcome: Number of patients with 30% improvement in pain severity [ Time Frame: randomization to 3 weeks ]

To compare the effects of treatment with intravenous Sodium Thiosulfate Injection vs. placebo for the proportion of patients (responders) who achieve a ≥ 30% reduction based upon pain intensity score (modified BPI/SF).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Secondary Endpoint-a: Number of patients with stabilization or improvement in calciphylaxis skin lesions. [ Time Frame: randomization to 3 weeks ]
    Proportion of patients who achieve improvement or stabilization (i.e., not worsening) of skin lesions.
  • Secondary Endpoint-b: Occurence of surgical debridement of skin lesions and/or amputation. [ Time Frame: during week 3 ]
    Occurence of surgical debridement of skin lesions and/or amputation.
  • Secondary Endpoint-c: Occurrence of surgical debridement of skin lesions and/or amputation. [ Time Frame: randomization to 3 weeks ]
    Occurrence of surgical debridement of skin lesions and/or amputation.
  • Secondary Endpoint-d: Time to achieve ≥ 30% improvement in pain severity [ Time Frame: randomization to 3 weeks ]
    Time in days when a patient achieves a ≥ 30% improvement based upon pain intensity score (modified BPI/SF).


Original Secondary Outcome: Same as current

Information By: Hope Pharmaceuticals

Dates:
Date Received: March 29, 2017
Date Started: May 2017
Date Completion: May 2019
Last Updated: May 11, 2017
Last Verified: May 2017