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Randomized Double Blind Placebo Controlled Trial of Sodium Thiosulfate for the Treatment of Pain Associated With Calcific Uremic Arteriolopath

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ClinicalTrials.gov Identifier: NCT02527213
Recruitment Status : Terminated (Company decision)
First Posted : August 18, 2015
Last Update Posted : January 23, 2017
Sponsor:
Information provided by (Responsible Party):
American Regent, Inc.

Brief Summary:
To evaluate the efficacy of Sodium Thiosulfate (STS) compared to placebo, in reducing analgesic requirement in subjects with calcific uremic arteriolopathy (CUA) during an initial 28-day treatment phase.

Condition or disease Intervention/treatment Phase
Calciphylaxis Calcific Uremic Arteriolopathy Drug: Sodium thiosulfate Drug: Placebo Phase 3

Detailed Description:
Efficacy of Sodium Thiosulfate (STS) compared to placebo, in reducing analgesic requirement in subjects with calcific uremic arteriolopathy (CUA) during an initial 28-day treatment phase.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Double Blind Placebo Controlled Trial of Sodium Thiosulfate for the Treatment of Pain Associated With Calcific Uremic Arteriolopathy Followed by a Single Armed Extension Phase to Prospectively Observe Lesion Progression in the Presence of Sodium Thiosulfate Treatment
Study Start Date : January 30, 2015
Actual Primary Completion Date : August 29, 2016
Actual Study Completion Date : August 29, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sodium Thiosulfate
Sodium Thiosulfate at 25g in 100 ml normal sterile saline (NSS)
Drug: Sodium thiosulfate
Additional treatment(s) due to lesion progression When intervention occurs, the date of the intervening event should be recorded in the source documents and the (CRF). The subject should continue in the study as scheduled.

Placebo Comparator: Placebo
similarly-formulated placebo in 100 ml NSS
Drug: Placebo
Additional treatment(s) due to lesion progression When intervention occurs, the date of the intervening event should be recorded in the source documents and the (CRF). The subject should continue in the study as scheduled.




Primary Outcome Measures :
  1. Reduction in Analgesic Requirement [ Time Frame: up to 28 Days ]
    The length of time in days, from first treatment with blinded study drug; to when subject requires rescue analgesic



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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:

  1. Males or females ≥18 years of age who are able to give informed consent.
  2. Calcific uremic arteriolopathy (CUA), either newly-diagnosed or pre-existing, currently on STS or not yet treated with STS and either not on pain medication or on a stable pain medication regimen. The diagnosis of calciphylaxis can be made when:

    • The following clinical features are all present, or two (2) of the following clinical features and typical histopathological findings are present.

Clinical features:

  1. A patient on chronic hemodialysis for chronic kidney disease or with a GFR of less than 15/ml/min/1.73 m2
  2. More than 2 painful and non-treatable skin ulcers with concomitant painful purpura
  3. Painful and non-treatable skin ulcers on the trunk, extremities, or penis with concomitant painful purpura

Histopathological findings by skin biopsy when 3 clinical findings are not present:

  1. Necrosis and ulceration of the skin with calcification of the tunica media and internal elastic membrane of small to medium-sized arterioles of dermis and subcutaneous fat are essential for the diagnosis
  2. Concentric stenosis due to edematous intimal thickening is also seen in the small to medium-sized arterioles of dermis and subcutaneous fat
  3. End stage renal disease (ESRD) on chronic maintenance hemodialysis.
  4. Willingness to undergo washout of pre-existing STS treatment (if required by treatment allocation) and to continue in a double blind treatment period of 4 weeks, during which they might receive placebo.
  5. Ability to comply with all study requirements.

Exclusion Criteria:

  1. History of allergic or other adverse reaction to STS
  2. Current treatment with STS for indications other than CUA (e.g. cyanide poisoning)
  3. Currently on alternative treatment for CUA as listed below. Unless treatment has been discontinued for at least 1 month prior to the screening visit.

    1. Steroids
    2. Hyperbaric Oxygen
    3. Bisphosphonates
    4. Pentoxifylline
    5. Tissue Plasminogen Activator
    6. Luciliar sericata larvae (maggot therapy)
    7. On Cinacalcet for treatment for CUA (i.e. cinacalcet was either started or dose increased after the appearance of lesions)
  4. Any co-existing disease or problem that makes participation in the study unadvisable for the patient or compromises integrity of the study

    1. Cirrhosis of the liver
    2. History of congestive heart failure (New York Heart Association class III or IV) with multiple hospital admissions (at least 3 admissions in 6 months)
    3. Persistent and uncontrolled metabolic acidosis
  5. Chronic kidney disease or renal transplant patients with diagnosis of calciphylaxis who are not on hemodialysis.
  6. Any other disease or condition which, in the judgment of the Investigator, would place a subject at undue risk by being enrolled in the trial, or cause inability to comply with the trial

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): NCT02527213


Locations
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United States, Alabama
Nephrology Consultants
Huntsville, Alabama, United States, 35805
United States, Indiana
Nephrology Association of Northern Indiana
Fort Wayne, Indiana, United States, 46804
United States, Pennsylvania
A.A. Northeast Clinical Research Center
Bethlehem, Pennsylvania, United States, 18017
Sponsors and Collaborators
American Regent, Inc.
Investigators
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Study Director: Linda Mundy, MD, PhD American Regent, Inc.

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Responsible Party: American Regent, Inc.
ClinicalTrials.gov Identifier: NCT02527213     History of Changes
Other Study ID Numbers: 1STS12001
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Sodium thiosulfate
Calciphylaxis
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases
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