NCT02527213

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

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: American Regent, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Calciphylaxis
• Calcific Uremic Arteriolopathy

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2015-01-30
• Primary completion: 2016-08-29
• Completion: 2016-08-29
• First posted: 2015-08-18
• Last updated: 2025-05-07

Locations

3 sites across 1 country: United States