Double-blind Trial of Sodium Thiosulfate for the Treatment of Pain Associated With Calcific Uremic Arteriolopathy

NCT02527213 | Withdrawn Phase 3

• 1 other identifier: 1STS12001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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.

Conditions

Calciphylaxis; Calcific Uremic Arteriolopathy

Outcome Measures

Primary Outcomes (1)

• Reduction in Analgesic Requirement

  The length of time in days, from first treatment with blinded study drug; to when subject requires rescue analgesic

  up to 28 Days

Study Arms (2)

Sodium Thiosulfate

EXPERIMENTAL

Sodium Thiosulfate at 25g in 100 ml normal sterile saline (NSS)

Drug: Sodium thiosulfate

Placebo

PLACEBO COMPARATOR

similarly-formulated placebo in 100 ml NSS

Drug: Placebo

Interventions

Sodium thiosulfate DRUG

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.

Sodium Thiosulfate

Placebo DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 glomerular filtration rate (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.

You may not qualify if:

• 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
• Lucilia 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.

Sponsors & Collaborators

• American Regent, Inc.: lead

Study Sites (3)

Nephrology Consultants

Huntsville, Alabama, 35805, United States

Location

Nephrology Association of Northern Indiana

Fort Wayne, Indiana, 46804, United States

Location

A.A. Northeast Clinical Research Center

Bethlehem, Pennsylvania, 18017, United States

Location

MeSH Terms

Conditions

Calciphylaxis

Interventions

sodium thiosulfate

Condition Hierarchy (Ancestors)

Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Linda Mundy, MD, PhD

  American Regent, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2015
• First Posted: August 18, 2015
• Study Start: January 30, 2015
• Primary Completion: August 29, 2016
• Study Completion: August 29, 2016
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)