Double-blind Trial of Sodium Thiosulfate for the Treatment of Pain Associated With Calcific Uremi… (NCT02527213) | Clinical Trial Compass
WithdrawnPhase 3
Double-blind Trial of Sodium Thiosulfate for the Treatment of Pain Associated With Calcific Uremic Arteriolopathy
Stopped: Company decision -terminated on 30 October 2015
United States0Started 2015-01-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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:
✓. 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
✓. 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.
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.