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

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ClinicalTrials.gov Identifier: NCT03150420
Recruitment Status : Terminated (Inability to accrue subjects that met the exclusion criterion "Any prior (within the past 30 days) or current Sodium Thiosulfate treatment".)
First Posted : May 12, 2017
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Hope Pharmaceuticals

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Calciphylaxis Drug: Sodium Thiosulfate Drug: Placebo-Normal Saline Phase 3

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Intravenous Sodium Thiosulfate for Acute Calciphylaxis Treatment: A Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Trial
Actual Study Start Date : May 24, 2017
Actual Primary Completion Date : April 15, 2020
Actual Study Completion Date : April 15, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Sodium Thiosulfate
Sodium Thiosulfate Injection (25 grams sodium thiosulfate)
 Drug: Sodium Thiosulfate
Intravenous Sodium Thiosulfate Injection (25 grams sodium thiosulfate) to be administered each hemodialysis session (3 times weekly) for 3 weeks
Other Name: Intravenous Sodium Thiosulfate Injection
Placebo Comparator: Placebo-Normal Saline
0.9% sodium chloride injection, USP (normal saline)
 Drug: Placebo-Normal Saline
Placebo: to be administered each hemodialysis session (3 times weekly) for 3 weeks
Other Name: 0.9% sodium chloride solution


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with 30% improvement in pain severity [ Time Frame: randomization to 3 weeks ]
    To compare the effects of treatment with intravenous Sodium Thiosulfate Injection vs. placebo for the proportion of patients (responders) who achieve a ≥ 30% reduction based upon pain intensity score (modified BPI/SF).


Secondary Outcome Measures :
  1. Secondary Endpoint-a: Number of patients with stabilization or improvement in calciphylaxis skin lesions. [ Time Frame: randomization to 3 weeks ]
    Proportion of patients who achieve improvement or stabilization (i.e., not worsening) of skin lesions.

  2. Secondary Endpoint-b: Occurence of surgical debridement of skin lesions and/or amputation. [ Time Frame: during week 3 ]
    Occurence of surgical debridement of skin lesions and/or amputation.

  3. Secondary Endpoint-c: Occurrence of surgical debridement of skin lesions and/or amputation. [ Time Frame: randomization to 3 weeks ]
    Occurrence of surgical debridement of skin lesions and/or amputation.

  4. Secondary Endpoint-d: Time to achieve ≥ 30% improvement in pain severity [ Time Frame: randomization to 3 weeks ]
    Time in days when a patient achieves a ≥ 30% improvement based upon pain intensity score (modified BPI/SF).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03150420


Locations
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Sponsors and Collaborators
Hope Pharmaceuticals
Investigators
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Study Director: Craig Sherman, MD Hope Pharmaceuticals
More Information
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Responsible Party: Hope Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03150420    
Other Study ID Numbers: ST-001
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hope Pharmaceuticals:
calciphylaxis
calcific uremic arteriolopathy, calcinosis
calcium metabolism disorders
metabolic diseases
sodium thiosulfate
Additional relevant MeSH terms:
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Calciphylaxis
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases
Sodium thiosulfate
Antidotes
Protective Agents
Physiological Effects of Drugs
 Antioxidants
Molecular Mechanisms of Pharmacological Action
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Chelating Agents
Sequestering Agents