A Phase 3 Clinical Trial of Intravenous Sodium Thiosulfate in Acute Calciphylaxis Patients
NCT ID: NCT03150420
Last Updated: 2020-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
29 participants
INTERVENTIONAL
2017-05-24
2020-04-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Sodium Thiosulfate
Sodium Thiosulfate Injection (25 grams sodium thiosulfate)
Sodium Thiosulfate
Intravenous Sodium Thiosulfate Injection (25 grams sodium thiosulfate) to be administered each hemodialysis session (3 times weekly) for 3 weeks
Placebo-Normal Saline
0.9% sodium chloride injection, USP (normal saline)
Placebo-Normal Saline
Placebo: to be administered each hemodialysis session (3 times weekly) for 3 weeks
Interventions
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Sodium Thiosulfate
Intravenous Sodium Thiosulfate Injection (25 grams sodium thiosulfate) to be administered each hemodialysis session (3 times weekly) for 3 weeks
Placebo-Normal Saline
Placebo: to be administered each hemodialysis session (3 times weekly) for 3 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Hope Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Craig Sherman, MD
Role: STUDY_DIRECTOR
Hope Pharmaceuticals
Locations
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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
Countries
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Other Identifiers
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ST-001
Identifier Type: -
Identifier Source: org_study_id
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