- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02527213
Randomized Double Blind Placebo Controlled Trial of Sodium Thiosulfate for the Treatment of Pain Associated With Calcific Uremic Arteriolopath
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alabama
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Huntsville, Alabama, United States, 35805
- Nephrology Consultants
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Indiana
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Fort Wayne, Indiana, United States, 46804
- Nephrology Association of Northern Indiana
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Pennsylvania
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Bethlehem, Pennsylvania, United States, 18017
- A.A. Northeast Clinical Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males or females ≥18 years of age who are able to give informed consent.
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:
- A patient on chronic hemodialysis for chronic kidney disease or with a GFR of less than 15/ml/min/1.73 m2
- More than 2 painful and non-treatable skin ulcers with concomitant painful purpura
- 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:
- 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
- Concentric stenosis due to edematous intimal thickening is also seen in the small to medium-sized arterioles of dermis and subcutaneous fat
- End stage renal disease (ESRD) on chronic maintenance hemodialysis.
- 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.
- Ability to comply with all study requirements.
Exclusion Criteria:
- History of allergic or other adverse reaction to STS
- Current treatment with STS for indications other than CUA (e.g. cyanide poisoning)
Currently on alternative treatment for CUA as listed below. Unless treatment has been discontinued for at least 1 month prior to the screening visit.
- Steroids
- Hyperbaric Oxygen
- Bisphosphonates
- Pentoxifylline
- Tissue Plasminogen Activator
- Luciliar sericata larvae (maggot therapy)
- On Cinacalcet for treatment for CUA (i.e. cinacalcet was either started or dose increased after the appearance of lesions)
Any co-existing disease or problem that makes participation in the study unadvisable for the patient or compromises integrity of the study
- Cirrhosis of the liver
- History of congestive heart failure (New York Heart Association class III or IV) with multiple hospital admissions (at least 3 admissions in 6 months)
- Persistent and uncontrolled metabolic acidosis
- Chronic kidney disease or renal transplant patients with diagnosis of calciphylaxis who are not on hemodialysis.
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sodium Thiosulfate
Sodium Thiosulfate at 25g in 100 ml normal sterile saline (NSS)
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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.
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Placebo Comparator: Placebo
similarly-formulated placebo in 100 ml NSS
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in Analgesic Requirement
Time Frame: up to 28 Days
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The length of time in days, from first treatment with blinded study drug; to when subject requires rescue analgesic
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up to 28 Days
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Linda Mundy, MD, PhD, American Regent, Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Calcium Metabolism Disorders
- Calcinosis
- Calciphylaxis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Protective Agents
- Anti-Bacterial Agents
- Antioxidants
- Antidotes
- Antitubercular Agents
- Chelating Agents
- Sequestering Agents
- Sodium thiosulfate
Other Study ID Numbers
- 1STS12001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Calciphylaxis
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Association ECHOElsan; European Clinical Trial Experts NetworkCompletedRheopheresis | Calcifying Uremic Arteriolopathy | Uremic CalciphylaxisFrance
-
University of Wisconsin, MadisonShireCompleted
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University of SydneyNorthern Care Alliance NHS Foundation Trust; Waitemata District Health Board; Australasian Kidney Trials NetworkRecruiting
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Hope PharmaceuticalsTerminatedA Phase 3 Clinical Trial of Intravenous Sodium Thiosulfate in Acute Calciphylaxis Patients (CALISTA)CalciphylaxisUnited States, Canada, United Kingdom
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Nantes University HospitalCompleted
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Hope PharmaceuticalsTerminatedCalciphylaxisUnited States
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Sanifit Therapeutics S. A.CompletedCalciphylaxis | Calcific Uremic ArteriolopathyUnited States, Belgium, United Kingdom, Spain, Germany, Poland
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