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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 : Recruiting
First Posted : May 12, 2017
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
Hope Pharmaceuticals

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 111 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
Estimated Primary Completion Date : May 24, 2020
Estimated Study Completion Date : May 24, 2020

Resource links provided by the National Library of Medicine


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




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).



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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

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


Contacts
Contact: Craig Sherman, MD 480-607-1970 sherman@hopepharm.com

Locations
United States, Illinois
Northwestern University Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Jennifer Tuazon, MD    312-503-1887    jtuazon@nm.org   
Contact: Patrick Fox    312-503-1887    patrick.fox@northwestern.edu   
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Vinod Bansal, MD    708-216-3306    vbansal@lumc.edu   
Contact: Sana Iqbal    708-216-3268    siqbal5@luc.edu   
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Lama Noureddine, MD    319-356-4409    lama-noureddine@uiowa.edu   
Contact: Ann Rhomberg    319-356-0575    ann-rhomberg@uiowa.edu   
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Sagar Nigwekar, MD    617-726-7872    snigwekar@mgh.harvard.edu   
Contact: Shananssa Percy    617-643-6718    lmercier-lafond@mgh.harvard.edu   
United States, New York
Veterans Administration Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Elvira Gosmanova, MD    518-626-6463    Elvira.Gosmanova@va.gov   
Contact: Elissa Ball    518-626-6447    elissa.ball@va.gov   
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Robert Heyka, MD    216-444-8896    heykar@ccf.org   
Contact: Dianna Sendry, RN    216-444-0486    sendred2@ccf.org   
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02914
Contact: Maroun Azar, MD    401-444-5212    mazar@lifespan.org   
Contact: Sari Dahn    401-606-3387    sari.danh@lifespan.org   
United States, Virginia
Veterans Administration Medical Center Recruiting
Salem, Virginia, United States, 24153
Contact: Devamita Dev, MD    540-982-2463 ext 2444    devasmita.dev@va.gov   
Contact: Leslie McNeil    540-982-2463 ext 4663    lesley.mcneil@va.gov   
Canada, Alberta
University of Calgary Foothills Medical Center Recruiting
Calgary, Alberta, Canada, T2W 1S7
Contact: Jennifer MacRae, MD    403-944-2566    jmmacrae@ucalgary.ca   
Contact: Sheilah Heal, RN    403-955-6385    heal@ucalgary.ca   
Sponsors and Collaborators
Hope Pharmaceuticals
Investigators
Study Director: Craig Sherman, MD Hope Pharmaceuticals

Responsible Party: Hope Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03150420     History of Changes
Other Study ID Numbers: ST-001
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Antioxidants
Calciphylaxis
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases
Sodium thiosulfate
Antidotes
Protective Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Chelating Agents
Sequestering Agents