Sodium Thiosulfate Treatment of Vascular Calcification in ESRD

NCT00568399 | Completed Results DMC

• 1 other identifier: HRPO 07-0331
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiovascular disease is the major cause of death in the hemodialysis population and calcification of the major arteries (coronary, aorta, and carotid) are a play a central role in this process. The major causes of the calcification are many, including high levels of phosphorus, low levels of inhibitors of calcification, positive calcium balance, and oxidative stress. Once vascular calcification is present, it is usually progressive. There is no known treatment to reverse established vascular calcification. Sodium thiosulfate has been used extensively and safely to treat calcific uremic arteriopathy (a disease, in part due to calcification of small arteries) in dialysis patients. It increases the solubility of calcium by up to 100,000 fold and is also a potent anti-oxidant. It therefore has to potential to also decrease the amount of calcium in large arteries in dialysis patients and, hence improve survival. We will study hemodialysis (HD) patients at high risk for cardiovascular disease and death by obtaining a multidetector computerized tomography (MDCT) Scan of the coronary arteries, carotid arteries and aorta and an assessment of coronary artery stenoses by a simultaneous intravenous infusion of contrast. At the same setting, we will perform tests of pulse wave velocity (PWV) and carotid ultrasound carotid intima-media thickness(CIMT)studies. In those patients at high risk for cardiovascular death, defined as a coronary artery calcification score (CACS)of greater than 50, sodium thiosulfate at a dose of 12.5-25 gm/1.73 M2 will be infused over 15-30 minutes after each dialysis treatment for 5 months. The above studies will then be repeated.

Conditions

Complication of Hemodialysis; Cardiovascular Diseases

Keywords

Coronary; Calcification; Dialysis; Thiosulfate; Cardiovascular

Outcome Measures

Primary Outcomes (1)

• Change in Annualized Coronary Calcium Volume Score After Treatment With Sodium Thiosulfate.

  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.

  5 months

Study Arms (1)

Active Treatment

EXPERIMENTAL

This is the only arm and involves active treatment with sodium thiosulfate in those subjects with high coronary artery calcium scores.

Drug: sodium thiosulfate

Interventions

sodium thiosulfate DRUG

sodium thiosulfate 12.5-25 gm/M2 after each thrice weekly hemodialysis treatments for 5 months.

Active Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hemodialysis patient with thrice weekly treatments
• Coronary artery calcium score greater than 50
• Age greater than 18
• Compliant with hemodialysis treatments
• Informed consent

You may not qualify if:

• Allergy to sodium thiosulfate
• Pregnancy
• Incarceration
• Enrollment in another study
• Life expectancy less than 5 months
• Expectation of recovery of renal function
• Urine output of greater than 200 ml/day or contrast allergy will not receive intravenous contrast

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Barnes-Jewish Hospital: collaborator
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Calcinosis

Interventions

sodium thiosulfate

Condition Hierarchy (Ancestors)

Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: James Delmez, MD
• Organization: Washington University School of Medicine

jdelmez@dom.wustl.edu

314 362 7207

Study Officials

• James A Delmez, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2007
• First Posted: December 6, 2007
• Study Start: December 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: November 20, 2012
• Results First Posted: November 6, 2012

Record last verified: 2012-11

Locations

US (1)