Intravenous Sodium Thiosulfate on Coronary Calcification in Patients on Hemodialysis - Full Text View

Sponsored by:	Ramathibodi Hospital
Information provided by:	Ramathibodi Hospital
ClinicalTrials.gov Identifier:	NCT00720772

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 II

MedlinePlus related topics: Dialysis Kidney Failure

Drug Information available for: Sodium thiosulfate Sodium hyposulfite

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	The Treatment Effect of Intravenous Sodium Thiosulfate on Coronary Calcification in Patients on Hemodialysis

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
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: 25% intravenous (IV) sodium thiosulfate 100 ml IV drip twice/week post hemodialysis
B: No Intervention

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00720772

Contacts

Contact: Sinee Disthabanchong, M.D	+6622011116	tesdb@mahidol.ac.th
Contact: Surawat Adirekkiat, M.D.	+6622101116	surawat_adi@hotmail.com

Locations

Thailand, Bangkok
Ramathibodi Hospital	Recruiting
Phayathai, Bangkok, Thailand, 10400
Contact: Sinee Disthabanchong, M.D. +6622011116 tesdb@mahidol.ac.th
Principal Investigator: Sinee Disthabanchong, M.D.

Sponsors and Collaborators

Ramathibodi Hospital

Investigators

Principal Investigator:

Sinee Disthabanchong, M.D.

Ramathibodi Hospital, Mahidol University

More Information

Publications:

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.

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.

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.

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.

Responsible Party:	Ramathibodi Hospital. Mahidol University ( Sinee Disthabanchong, M.D. )
Study ID Numbers:	ID 02-51-31
Study First Received:	July 21, 2008
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00720772
Health Authority:	Thailand: Ethical Committee

Keywords provided by Ramathibodi Hospital:

coronary calcification
vascular calcification
sodium thiosulfate

Study placed in the following topic categories:

Calcinosis
Metabolic Diseases
Sodium thiosulfate
Metabolic disorder

Additional relevant MeSH terms:

Calcium Metabolism Disorders
Anti-Infective Agents
Anti-Bacterial Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Physiological Effects of Drugs
Chelating Agents
Antitubercular Agents
Protective Agents
Pharmacologic Actions
Antidotes

ClinicalTrials.gov processed this record on January 16, 2009