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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Calciphylaxis

In brief

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.

Key facts

Study ID

NCT03150420

Run by

Hope Pharmaceuticals

People needed

29

Starts

2017-05-24

Expected to finish

2020-04-15

Last updated by the study team

2020-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Informed of the investigational nature of the study and sign written informed consent
• Willing and able to adhere to all study-related procedures, including adherence to study medication regimen
• Male or female ≥18 years old
• End-stage renal disease on chronic hemodialysis
• Calciphylaxis with active skin lesion(s) of any morphological appearance (including but not limited to livedo, induration, ulceration, etc.) and tissue histology review consistent with calciphylaxis diagnosis. Histological features consistent with calciphylaxis will include soft tissue calcification, microthrombosis, and/or fibrointimal hyperplasia of dermal arterioles
• Acute pain associated with calciphylaxis lesions pain intensity score of ≥ 5 at initial screening on the modified BPI/SF scale
• Women of childbearing potential must have a pregnancy test (urine or serum [if anuric]) at screening and not be pregnant and willing to use an acceptable method of contraception for the entire duration of the study (3 weeks)

You may not qualify if…

• Peritoneal dialysis patients
• Current congestive heart failure exacerbation
• Baseline abnormalities related to QT prolongation (corrected QT interval > 470 ms), hypocalcemia (serum albumin-corrected calcium < 8 mg/dL ), metabolic acidosis (serum bicarbonate < 18 mmol/L, hypotension (resting systolic blood pressure while seated < 80), or interdialytic weight gain ≥ 4.0 kg
• History of ventricular arrhythmias including ventricular fibrillation or ventricular tachycardia associated with shortness of breath, dizziness, hypotension, or syncope
• Any prior (within the past 30 days) or current intravenous Sodium Thiosulfate Injection treatment
• Other investigational agent (drug, biologic, or device) study within the past 30 days and/or for the duration of the trial
• Pregnant or lactating women
• History of allergy to sulfites, thiosulfate, or any component in Sodium Thiosulfate Injection (sulfa allergy is not an exclusion criterion)
• Significant other acute or chronic concomitant diseases (including but not limited to hepatic, cardiovascular, pulmonary, or oncologic disease, sepsis, pulmonary edema, pulmonary embolism) that would be inconsistent with survival for at least 3 months
• Other serious concurrent or recent medical or psychiatric condition which, in the opinion of the Investigator, makes the patient unsuitable for participation in this study
• Ongoing application of dialysate admixed with iron salt e.g. ferric pyrophosphate during the entire trial period (patients who are on dialysate admixed with iron salt at screening are eligible if dialysate admixed with iron salt can be substituted with non-iron based dialysate and patients can be maintained on non-iron based dialysate therapy for the entire duration of trial period)
• Recent (within 1 week) history of surgical parathyroidectomy or scheduled for surgical parathyroidectomy during the course of the study
• History of opioid addiction

Where it is running

• Mayo Clinic — Jacksonville, Florida, United States
• Northwestern University Hospital — Chicago, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Veterans Administration Medical Center — Albany, New York, United States
• The Icahn School of Medicine at Mount Sinai Hospital — New York, New York, United States
• Sanford Health — Fargo, North Dakota, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• University of Virginia Health System — Charlottesville, Virginia, United States
• Veterans Administration Medical Center — Salem, Virginia, United States
• University of Calgary Foothills Medical Center — Calgary, Alberta, Canada
• University of Alberta Hospital — Edmonton, Alberta, Canada
• Health Sciences Centre Winnipeg — Winnipeg, Manitoba, Canada
• Kingston Health Sciences Centre — Kingston, Ontario, Canada
• Centre Hospitalier de l'Universite de Montreal — Montreal, Quebec, Canada
• Salford Royal Hospital NHS Foundation Trust — Salford, Manchester, United Kingdom
• Hammersmith Hospital — London, United Kingdom
• Churchill Hospital — Oxford, United Kingdom
• Lister Hospital — Stevenage, United Kingdom

Full record on ClinicalTrials.gov

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