Trial Outcomes & Findings for Sodium Thiosulfate Treatment of Vascular Calcification in ESRD (NCT NCT00568399)

NCT ID: NCT00568399

Last Updated: 2012-11-20

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 48 participants
• Primary outcome timeframe: 5 months
• Results posted on: 2012-11-20

Participant Flow

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)

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.

Participant milestones

Measure	Sodium Thiosulfate 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 Study STARTED	37
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Measure	Sodium Thiosulfate 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 Study Death	2
Overall Study Adverse Event	5
Overall Study Withdrawal by Subject	8

Baseline Characteristics

Sodium Thiosulfate Treatment of Vascular Calcification in ESRD

Baseline characteristics by cohort

Measure	Sodium Thiosulfate n=48 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants
Age, Categorical >=65 years	24 Participants n=5 Participants
Age Continuous	59 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Region of Enrollment United States	48 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 months

Population: This is a feasibility study and all eligible participants were invited to participate. Out of the 48 participates that started, but only 22 completed.

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.

Outcome measures

Measure	Sodium Thiosulfate n=22 Participants Treatment with sodium thiosulfate after each dialysis for 5 months
Change in Annualized Coronary Calcium Volume Score After Treatment With Sodium Thiosulfate.	6.6 mm3/year Standard Deviation 9.7

Adverse Events

Sodium Thiosulfate

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sodium Thiosulfate n=37 participants at risk 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.
Renal and urinary disorders Death due to retroperitoneal bleed	2.7% 1/37 • Number of events 1 • 5 months
Blood and lymphatic system disorders Death due to sepsis	2.7% 1/37 • Number of events 1 • 5 months

Other adverse events

Measure	Sodium Thiosulfate n=37 participants at risk 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.
Gastrointestinal disorders Nausea	13.5% 5/37 • 5 months

Additional Information

James Delmez, MD

Washington University School of Medicine

Phone: 314 362 7207

Email: jdelmez@dom.wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place