Intravenous Sodium Thiosulfate on Coronary Calcification in Patients on Hemodialysis

Vascular Calcification Clinical Trial

Official title:

The Treatment Effect of Intravenous Sodium Thiosulfate on Coronary Calcification in Patients on Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00720772
• Other study ID #: ID 02-51-31
• Status: Completed
• Phase: Phase 2
• First received: July 21, 2008
• Last updated: December 16, 2009
• Start date: July 2008
• Est. completion date: November 2009

Study information

• Verified date: December 2009
• Source: Ramathibodi Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• CAC score > 300

• Life expectancy > 6 months

• Dialysis vintage > 6 months

Exclusion Criteria:

• Non-compliance to hemodialysis

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Calcinosis
• Coronary Calcification
• Vascular Calcification

Intervention

Drug:
• 25% intravenous (IV) sodium thiosulfate
50 ml IV drip twice/week post hemodialysis

Locations

Country	Name	City	State
Thailand	Ramathibodi Hospital	Phayathai	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Ramathibodi Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (4)

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. — View 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. — View Citation

London GM, Guérin AP, Marchais SJ, Métivier 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CAC score		6 months	No
Secondary	Bone mineral density, calcium removal		6 months, 1 and 2 months	No