CALISTA - ST-001 / V. 9.1 / 23Oct2018
Research type
Research Study
Full title
A Phase 3, Intravenous Sodium Thiosulfate for Acute Calciphylaxis Treatment: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
IRAS ID
254999
Contact name
Craig Sherman
Contact email
Sponsor organisation
Hope Pharmaceuticals Ltd
Eudract number
2018-002751-15
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
127773, US IND Number
Duration of Study in the UK
2 years, 4 months, 30 days
Research summary
The CALISTA-study is a multicenter research phase-3-study sponsored by Hope Pharmaceuticals. It is a double-blind, placebo-controlled study and will enroll a total of approximately 111 male and female patients suffering from calciphylaxis in Canada, UK and USA.
Calciphylaxis, also known as calcific uremic arteriolopathy, is associated with significant morbidity and mortality in chronic dialysis patients. Calciphylaxis presents with intensely painful skin lesions that frequently ulcerate (become inflammatory and often suppurating) and become infected.
Pain control remains one of the most important and challenging aspects of calciphylaxis management. Improvement in calciphylaxis pain in the first 2-3 weeks of intravenous Sodium Thiosulfate Injection treatment has been described, and relief of pain appears to indicate skin lesion improvement. To date, no controlled trial has been conducted to examine the efficacy of Sodium Thiosulfate on acute calciphylaxis-associated pain.
The purpose of this research study is to assess the efficacy and safety of Sodium Thiosulfate infusion to treat calciphylaxis as measured by a decrease in acute calciphylaxis-associated pain. The proposed dose and schedule is intravenous (IV) Sodium Thiosulfate infusion (25 grams Sodium Thiosulfate as 100 mL Sodium Thiosulfate Injection diluted with D5W to 900 mL) to be administered in the last 60 minutes of each haemodialysis session for 3 weeks.
Each patient will participate for a total of 4 weeks, including screening phase, run-in phase, and a 3-week double-blind treatment phase. Patients will be contacted 6 months after start of treatment to determine survival status. The entire duration of the study, including recruitment and data analysis, is expected to be 2 years.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
19/NE/0022
Date of REC Opinion
21 Mar 2019
REC opinion
Further Information Favourable Opinion