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Abstract: INFO33

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

Session Information

  • Informational Posters
    October 25, 2018 | Location: Exhibit Hall, San Diego Convention Center
    Abstract Time: 10:00 AM - 12:00 PM

Category:

  • No subcategory defined

Authors

  • Nigwekar, Sagar U., Massachusetts General Hospital, Cambridge, Massachusetts, United States
  • Sherman, Craig, Hope Pharmaceuticals, Scottsdale, Arizona, United States
Description

Calciphylaxis is a rare, life-threatening syndrome of vascular calcification characterized by occlusion of microvessels in the subcutaneous tissue and dermis resulting in painful, ischemic skin lesions. Calciphylaxis predominantly affects patients with end-stage renal disease (ESRD) and has no approved therapy.

Sodium thiosulfate is an agent with possible antioxidant, calcium-chelating, and/or vasodilatory properties. In observational studies, intravenous sodium thiosulfate has been suggested to improve calciphylaxis skin lesions. However, data from randomized clinical trial are lacking.

The current study is an international, phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of intravenous sodium thiosulfate injection for treatment of acute calciphylaxis-associated pain. Eligible patients will be randomized to Sodium Thiosulfate Injection (25 grams) or placebo (0.9% sodium chloride) administered intravenously with hemodialysis session (3 times weekly) for 3 weeks. The study is recruiting patients ≥18 years of age who meet the following criteria: 1) ESRD on chronic hemodialysis, 2) calciphylaxis with active skin lesion(s) and tissue histology consistent with calciphylaxis diagnosis, and 3) 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 include peritoneal dialysis, current congestive heart failure exacerbation, or abnormalities related to QT prolongation, hypocalcemia, metabolic acidosis, or interdialytic weight gain. The primary outcome measure is the proportion of patients who achieve a ≥ 30% reduction based upon pain intensity score (modified BPI/SF). Key secondary outcomes include the proportion of patients who achieve improvement or stabilization of skin lesions and the occurrence of surgical debridement of skin lesions and/or amputation. The trial also includes safety and pharmacokinetic outcomes.

The trial (ClinicalTrials.gov ID: NCT03150420) is sponsored by Hope Pharmaceuticals and is currently enrolling patients. Information on clinical trial sites can be obtained from Dr. Sagar Nigwekar (phone: 617-726-7872, email: snigwekar@mgh.harvard.edu) or from Dr. Craig Sherman (phone: 480-607-1970, email: sherman@hopepharm.com).

Funding

  • Hope Pharmaceuticals