CALISTA trial

(Calciphylaxis pain treatment with Intravenous Sodium Thiosulfate)

 

A Phase 3, Intravenous Sodium Thiosulfate for Acute Calciphylaxis Treatment: A Randomized Placebo-controlled Clinical Trial (NCT03150420)

CALISTA is a phase 3 clinical trial looking at the effects of sodium thiosulfate in patients with calciphylaxis who are currently on dialysis. This three week study aims to determine the effectiveness and safety of sodium thiosulfate by looking at daily pain scores and legion size. You would receive the study medication with each dialysis session for the length of the study.

 

Principal Investigator: Sagar Nigwekar MD, MMSc,

Massachusetts General Hospital, Office phone: 617 726 7872,

Cell phone: 585 729 8636, Email: snigwekar@mgh.Harvard.edu

 

Sponsor: Hope Pharmaceuticals

 

Key inclusion criteria

• 18 years of age or older
• End-stage renal disease on chronic hemodialysis
• Calciphylaxis with active skin lesion(s) and tissue histology consistent with calciphylaxis diagnosis,
• Acute pain associated with calciphylaxis lesions pain intensity score of ≥ 5 at initial screening on the modified Brief Pain Inventory (BPI)/SF (Short Form) scale.

Key exclusion criteria

• Peritoneal dialysis patients
• Current congestive heart failure exacerbation
• Prior (within the past 30 days) or current intravenous Sodium Thiosulfate Injection treatment
• Baseline abnormalities related to QT prolongation, hypocalcemia, metabolic acidosis, and hypotension
• Significant interdialytic weight gain

Outcomes

Primary:

• Proportion of patients who achieve a ≥ 30% reduction based upon pain intensity score (modified BPI/SF)

Secondary:

• Proportion of patients who achieve improvement or stabilization of skin lesions
• Occurrence of surgical debridement of skin lesions and/or amputation
• Time to achieve ≥ 30% improvement in pain severity