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Completed

NCT Number: NCT00720772

Intravenous Sodium Thiosulfate on Coronary Calcification in Patients on Hemodialysis

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

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Key information

Conditions

Coronary Calcification Calcinosis Calcium Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Calcification

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ramathibodi Hospital

Phayathai, Bangkok, 10400, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Non-compliance to hemodialysis

Treatment and study plan

25% intravenous (IV) sodium thiosulfate

Drug

50 ml IV drip twice/week post hemodialysis

Primary outcomes

  1. CAC score

    Time frame: 6 months

Secondary outcomes

  1. Bone mineral density, calcium removal

    Time frame: 6 months, 1 and 2 months

Sponsors and collaborators

Lead sponsor

Ramathibodi Hospital

Other

Registry information

Official study title

The Treatment Effect of Intravenous Sodium Thiosulfate on Coronary Calcification in Patients on Hemodialysis

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 23, 2008
Registry last updated
Dec 17, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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