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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Reduction in Analgesic Requirement

Timeframe: up to 28 Days

Trial details

NCT IDNCT02527213

SponsorAmerican Regent, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-08-29

View on ClinicalTrials.gov More Calciphylaxis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria