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Intravenous Sodium Thiosulfate on Coronary Calcification in Patients on Hemodialysis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00720772
First Posted: July 23, 2008
Last Update Posted: December 17, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ramathibodi Hospital
  Purpose
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
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

Resource links provided by NLM:


Further study details as provided by Ramathibodi Hospital:

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

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

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.
  Eligibility

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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-compliance to hemodialysis
  Contacts and Locations
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


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

Publications:
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 Submitted: July 21, 2008
First Posted: July 23, 2008
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:
Calcinosis
Vascular Calcification
Calcium Metabolism Disorders
Metabolic Diseases
Sodium thiosulfate
Antidotes
Protective Agents
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Chelating Agents
Sequestering Agents