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Intravenous Sodium Thiosulfate on Coronary Calcification in Patients on Hemodialysis

Primary Purpose

Coronary Calcification, Vascular Calcification

Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
25% intravenous (IV) sodium thiosulfate
Sponsored by
Ramathibodi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Calcification focused on measuring coronary calcification, vascular calcification, sodium thiosulfate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-compliance to hemodialysis

Sites / Locations

  • Ramathibodi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

CAC score

Secondary Outcome Measures

Bone mineral density, calcium removal

Full Information

First Posted
July 21, 2008
Last Updated
December 16, 2009
Sponsor
Ramathibodi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00720772
Brief Title
Intravenous Sodium Thiosulfate on Coronary Calcification in Patients on Hemodialysis
Official Title
The Treatment Effect of Intravenous Sodium Thiosulfate on Coronary Calcification in Patients on Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ramathibodi Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Calcification, Vascular Calcification
Keywords
coronary calcification, vascular calcification, sodium thiosulfate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
25% intravenous (IV) sodium thiosulfate
Intervention Description
50 ml IV drip twice/week post hemodialysis
Primary Outcome Measure Information:
Title
CAC score
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Bone mineral density, calcium removal
Time Frame
6 months, 1 and 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: CAC score > 300 Life expectancy > 6 months Dialysis vintage > 6 months Exclusion Criteria: Non-compliance to hemodialysis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sinee Disthabanchong, M.D.
Organizational Affiliation
Ramathibodi Hospital, Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ramathibodi Hospital
City
Phayathai
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
10816185
Citation
Goodman WG, Goldin J, Kuizon BD, Yoon C, Gales B, Sider D, Wang Y, Chung J, Emerick A, Greaser L, Elashoff RM, Salusky IB. Coronary-artery calcification in young adults with end-stage renal disease who are undergoing dialysis. N Engl J Med. 2000 May 18;342(20):1478-83. doi: 10.1056/NEJM200005183422003.
Results Reference
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PubMed Identifier
12937218
Citation
London GM, Guerin AP, Marchais SJ, Metivier F, Pannier B, Adda H. Arterial media calcification in end-stage renal disease: impact on all-cause and cardiovascular mortality. Nephrol Dial Transplant. 2003 Sep;18(9):1731-40. doi: 10.1093/ndt/gfg414.
Results Reference
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PubMed Identifier
15067517
Citation
Matsuoka M, Iseki K, Tamashiro M, Fujimoto N, Higa N, Touma T, Takishita S. Impact of high coronary artery calcification score (CACS) on survival in patients on chronic hemodialysis. Clin Exp Nephrol. 2004 Mar;8(1):54-8. doi: 10.1007/s10157-003-0260-0.
Results Reference
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PubMed Identifier
15168392
Citation
Cicone JS, Petronis JB, Embert CD, Spector DA. Successful treatment of calciphylaxis with intravenous sodium thiosulfate. Am J Kidney Dis. 2004 Jun;43(6):1104-8. doi: 10.1053/j.ajkd.2004.03.018.
Results Reference
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Intravenous Sodium Thiosulfate on Coronary Calcification in Patients on Hemodialysis

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