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



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:4/4/2019
Start Date:May 24, 2017
End Date:May 24, 2020
Contact:Craig Sherman, MD
Email:sherman@hopepharm.com
Phone:480-607-1970

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A Phase 3, Intravenous Sodium Thiosulfate for Acute Calciphylaxis Treatment: A Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Trial

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.

This Phase 3, 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. Acute calciphylaxis-
associated pain intensity will be the primary outcome measure.

Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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
We found this trial at
12
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-726-7872
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Phone: 216-444-8896
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Phone: 904-953-2072
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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Jacksonville, FL
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Phone: 401-444-5212
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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113 Holland Avenue
Albany, New York 12208
Phone: 518-626-6463
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Calgary, Alberta
Phone: 403-944-2566
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
Phone: 434-924-5125
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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Chicago, Illinois 60611
Phone: 312-503-1887
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Fargo, North Dakota 58122
Phone: 701-234-6090
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Fargo, ND
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Phone: 319-356-4409
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Phone: 708-216-3306
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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Salem, Virginia 24153
Phone: 540-982-2463
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