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Sodium Thiosulfate Treatment of Vascular Calcification in ESRD

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ClinicalTrials.gov Identifier: NCT00568399
Recruitment Status : Completed
First Posted : December 6, 2007
Results First Posted : November 6, 2012
Last Update Posted : November 20, 2012
Sponsor:
Collaborators:
Barnes-Jewish Hospital
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Complication of Hemodialysis
Cardiovascular Diseases
Intervention Drug: sodium thiosulfate
Enrollment 48
Recruitment Details Patients treated with chronic hemodialysis for ESRD at 2 Washington University units were recruited to undergo a battery of cardiovascular tests including CT quantitation (MDCT) of vascular calcification and possible treatment with sodium thiosulfate (see Am J Nephrol 2011;33:131-138)
Pre-assignment Details All patients with a coronary artery calcium score of greater than 50 Angstrom scores were begun on treatment with sodium thiosulfate after each dialysis for 5 months and the battery of cardiovascular tests were repeated in those who completed the 5 months of treatment.
Arm/Group Title Sodium Thiosulfate
Hide Arm/Group Description Treatment with sodium thiosulfate after each dialysis for 5 months and the battery of cardiovascular tests were repeated in those who completed the 5 months of treatment.subjects with high coronary artery calcium scores.
Period Title: Overall Study
Started 37
Completed 22 [1]
Not Completed 15
Reason Not Completed
Death             2
Adverse Event             5
Withdrawal by Subject             8
[1]
Of 48 subject enrolled, 37 initiated sodium thiosulfate treatment. 22 completed the entire protocol
Arm/Group Title Sodium Thiosulfate
Hide Arm/Group Description Treatment with sodium thiosulfate after each dialysis for 5 months and the battery of cardiovascular tests were repeated in those who completed the 5 months of treatment.subjects with high coronary artery calcium scores.
Overall Number of Baseline Participants 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
<=18 years
0
   0.0%
Between 18 and 65 years
24
  50.0%
>=65 years
24
  50.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants
59  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
Female
18
  37.5%
Male
30
  62.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 48 participants
48
1.Primary Outcome
Title Change in Annualized Coronary Calcium Volume Score After Treatment With Sodium Thiosulfate.
Hide Description We will compare the annualized coronary calcium volume score obtained at the baseline CT of the coronary arteries with another CT obtained of the same coronary arteries following 5 months of sodium thiosulfate treatment.
Time Frame 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
This is a feasibility study and all eligible participants were invited to participate. Out of the 48 participates that started, but only 22 completed.
Arm/Group Title Sodium Thiosulfate
Hide Arm/Group Description:
Treatment with sodium thiosulfate after each dialysis for 5 months
Overall Number of Participants Analyzed 22
Geometric Mean (Standard Deviation)
Unit of Measure: mm3/year
6.6  (9.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sodium Thiosulfate
Comments This was a pilot study without a control group. There were no power calculations (see manuscript).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments Coronary calcium score after treatment compared to baseline
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 9.2
Parameter Dispersion
Type: Standard Deviation
Value: 0.987
Estimation Comments [Not Specified]
Time Frame 5 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sodium Thiosulfate
Hide Arm/Group Description Treatment with sodium thiosulfate after each dialysis for 5 months and the battery of cardiovascular tests were repeated in those who completed the 5 months of treatment.subjects with high coronary artery calcium scores.
All-Cause Mortality
Sodium Thiosulfate
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sodium Thiosulfate
Affected / at Risk (%) # Events
Total   2/37 (5.41%)    
Blood and lymphatic system disorders   
Death due to sepsis   1/37 (2.70%)  1
Renal and urinary disorders   
Death due to retroperitoneal bleed   1/37 (2.70%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sodium Thiosulfate
Affected / at Risk (%) # Events
Total   5/37 (13.51%)    
Gastrointestinal disorders   
Nausea *  5/37 (13.51%) 
*
Indicates events were collected by non-systematic assessment
This study did not enroll a prospective, randomized, placebo controlled, double-blind control group; therefore conclusive statements about the risks and benefits of thiosulfate cannot be made.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: James Delmez, MD
Organization: Washington University School of Medicine
Phone: 314 362 7207
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00568399     History of Changes
Other Study ID Numbers: HRPO 07-0331
First Submitted: December 5, 2007
First Posted: December 6, 2007
Results First Submitted: September 26, 2011
Results First Posted: November 6, 2012
Last Update Posted: November 20, 2012