NCT00720772

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

December 17, 2009

Status Verified

December 1, 2009

Enrollment Period

10 months

First QC Date

July 21, 2008

Last Update Submit

December 16, 2009

Conditions

Coronary CalcificationVascular Calcification

Keywords

coronary calcificationvascular calcificationsodium thiosulfate

Outcome Measures

Primary Outcomes (1)

  • CAC score

    6 months

Secondary Outcomes (1)

  • Bone mineral density, calcium removal

    6 months, 1 and 2 months

Study Arms (2)

A

EXPERIMENTAL
Drug: 25% intravenous (IV) sodium thiosulfate

B

NO INTERVENTION

Interventions

25% intravenous (IV) sodium thiosulfateDRUG

50 ml IV drip twice/week post hemodialysis

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Non-compliance to hemodialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ramathibodi Hospital

Phayathai, Bangkok, 10400, Thailand

Location

Related Publications (4)

  • 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.

    PMID: 10816185BACKGROUND

  • 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.

    PMID: 12937218BACKGROUND

  • 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.

    PMID: 15067517BACKGROUND

  • 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.

    PMID: 15168392BACKGROUND

MeSH Terms

Conditions

Vascular Calcification

Interventions

sodium thiosulfate

Condition Hierarchy (Ancestors)

CalcinosisCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Sinee Disthabanchong, M.D.

    Ramathibodi Hospital, Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 21, 2008

First Posted

July 23, 2008

Study Start

July 1, 2008

Primary Completion

May 1, 2009

Study Completion

November 1, 2009

Last Updated

December 17, 2009

Record last verified: 2009-12

Locations

TH(1)