Intravenous Sodium Thiosulfate on Coronary Calcification in Patients on Hemodialysis

This study has been completed.
Information provided by:
Ramathibodi Hospital Identifier:
First received: July 21, 2008
Last updated: December 16, 2009
Last verified: December 2009
The present study will examine the treatment effect of sodium thiosulfate on coronary calcification in patients on hemodialysis.

Condition Intervention Phase
Coronary Calcification
Vascular Calcification
Drug: 25% intravenous (IV) sodium thiosulfate
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Treatment Effect of Intravenous Sodium Thiosulfate on Coronary Calcification in Patients on Hemodialysis

Resource links provided by NLM:

Further study details as provided by Ramathibodi Hospital:

Primary Outcome Measures:
  • CAC score [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone mineral density, calcium removal [ Time Frame: 6 months, 1 and 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: July 2008
Study Completion Date: November 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: 25% intravenous (IV) sodium thiosulfate
50 ml IV drip twice/week post hemodialysis
No Intervention: B

Detailed 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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-compliance to hemodialysis
  Contacts and Locations
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Please refer to this study by its identifier: NCT00720772

Ramathibodi Hospital
Phayathai, Bangkok, Thailand, 10400
Sponsors and Collaborators
Ramathibodi Hospital
Principal Investigator: Sinee Disthabanchong, M.D. Ramathibodi Hospital, Mahidol University
  More Information

Responsible Party: Sinee Disthabanchong, M.D., Ramathibodi Hospital. Mahidol University Identifier: NCT00720772     History of Changes
Other Study ID Numbers: ID 02-51-31 
Study First Received: July 21, 2008
Last Updated: December 16, 2009
Health Authority: Thailand: Ethical Committee

Keywords provided by Ramathibodi Hospital:
coronary calcification
vascular calcification
sodium thiosulfate

Additional relevant MeSH terms:
Vascular Calcification
Calcium Metabolism Disorders
Metabolic Diseases
Sodium thiosulfate
Anti-Bacterial Agents
Anti-Infective Agents
Antitubercular Agents
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Protective Agents
Sequestering Agents processed this record on May 25, 2016