Intravenous Sodium Thiosulfate on Coronary Calcification... | NCT00720772

Studies
Intravenous Sodium Thiosulfate on Coronary Calcification in Patients on Hemodialysis

NCT00720772

Sponsor

Ramathibodi Hospital

Status

Completed

Last Update Posted

Dec 17, 2009Estimated

Enrollment

50Estimated

Phase

Phase 2

Conditions

Coronary Calcification
Vascular Calcification

Interventions

25% intravenous (IV) sodium thiosulfate

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

May 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Jul 21, 2008

First Submission Date that Met QC Criteria

Jul 21, 2008

First Posted Date

Jul 23, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2009

Last Update Posted Date

Dec 17, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental		Drug: 25% intravenous (IV) sodium thiosulfate
B	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
25% intravenous (IV) sodium thiosulfate	Drug	50 ml IV drip twice/week post hemodialysis	A

Measure	Description	Time Frame
CAC score		6 months

Measure	Description	Time Frame
Bone mineral density, calcium removal		6 months, 1 and 2 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Non-compliance to hemodialysis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sinee Disthabanchong, M.D.	Ramathibodi Hospital, Mahidol University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ramathibodi Hospital		Phayathai	Bangkok	10400	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10816185	Background	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.
12937218	Background

ID	Term
D002114	Calcinosis
D002128	Calcium Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases