Intravenous Sodium Thiosulfate on Coronary Calcification in Patients on Hemodialysis

Mahidol University

Status and phase: Completed; Phase 2

Conditions: Vascular Calcification; Coronary Calcification

Treatments: Drug: 25% intravenous (IV) sodium thiosulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT00720772

ID 02-51-31

Details and patient eligibility

About

The present study will examine the treatment effect of sodium thiosulfate on coronary calcification in patients on hemodialysis.

Full description

Coronary calcification (CAC) is prevalent among patients with end-stage renal disease (ESRD). High serum phosphate, the intake of calcium containing phosphate binder as well as dialysis vintage have been shown to be associated with the increasing prevalence of CAC. High CAC score examined by electron-beam CT scan or multi-slice CT scan associates with an increased cardiovascular mortality in ESRD. In series of case reports, intravenous sodium thiosulfate (STS) reduced the calcium burden in calcific uremic arteriopathy and soft tissue calcification. This was believed to be due to the calcium chelation effect of STS.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• CAC score > 300
• Life expectancy > 6 months
• Dialysis vintage > 6 months

Exclusion criteria

• Non-compliance to hemodialysis

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

50 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: 25% intravenous (IV) sodium thiosulfate

B

No Intervention group