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Intravenous Sodium Thiosulfate on Coronary Calcification in Patients on Hemodialysis

This study has been completed.
Sponsor:
Information provided by:
Ramathibodi Hospital
ClinicalTrials.gov Identifier:
NCT00720772
First received: July 21, 2008
Last updated: December 16, 2009
Last verified: December 2009
  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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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:
Calcinosis
Vascular Calcification
Calcium Metabolism Disorders
Metabolic Diseases
Sodium thiosulfate
Anti-Bacterial Agents
Anti-Infective Agents
Antidotes
Antioxidants
Antitubercular Agents
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Sequestering Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014