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Intravenous Sodium Thiosulfate on Coronary Calcification in Patients on Hemodialysis

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ClinicalTrials.gov Identifier: NCT00720772
Recruitment Status : Completed
First Posted : July 23, 2008
Last Update Posted : December 17, 2009
Information provided by:
Ramathibodi Hospital

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

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

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Treatment Effect of Intravenous Sodium Thiosulfate on Coronary Calcification in Patients on Hemodialysis
Study Start Date : July 2008
Primary Completion Date : May 2009
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Minerals
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A Drug: 25% intravenous (IV) sodium thiosulfate
50 ml IV drip twice/week post hemodialysis
No Intervention: B

Primary Outcome Measures :
  1. CAC score [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Bone mineral density, calcium removal [ Time Frame: 6 months, 1 and 2 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-compliance to hemodialysis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00720772

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

Responsible Party: Sinee Disthabanchong, M.D., Ramathibodi Hospital. Mahidol University
ClinicalTrials.gov Identifier: NCT00720772     History of Changes
Other Study ID Numbers: ID 02-51-31
First Posted: July 23, 2008    Key Record Dates
Last Update Posted: December 17, 2009
Last Verified: December 2009

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

Additional relevant MeSH terms:
Vascular Calcification
Calcium Metabolism Disorders
Metabolic Diseases
Sodium thiosulfate
Protective Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Chelating Agents
Sequestering Agents