The Pharmacologic Profile of Sodium Thiosulfate in Renal Failure and Healthy Volunteers

Renal Failure Clinical Trial

Official title:

The Pharmacologic Profile of Sodium Thiosulfate in Renal Failure and Healthy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01008631
• Other study ID #: Uehlinger-002
• Status: Completed
• Phase: N/A
• First received: November 5, 2009
• Last updated: October 12, 2011
• Start date: September 2009
• Est. completion date: August 2010

Study information

• Verified date: October 2011
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

The pharmacokinetics of sodium thiosulfate in humans with different degrees of renal failure and in healthy volunteers will be after two single shot applications.

Description:

Two single shot applications of i.v. sodium thiosulfate will be given to dialysis patients. One application will be given immediately before a dialysis session and the second dose will be given after the consecutive dialysis session.

In healthy volunteers sodium thiosulfate will be given only once. In both groups, dialysis patients and healthy volunteers, blood and urinary/dialysate samples will be collected at defined time points.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• healthy volunteer or patient with renal failure

Exclusion Criteria:

• pregnancy

• withdrawal of consent

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Failure
• Renal Insufficiency

Intervention

Drug:
• Sodium thiosulfate
6g of Sodium Thiosulfate are applicated in a short infusion over a time of 5 min

Locations

Country	Name	City	State
Switzerland	Department of Nephrology and Hypertension, University of Berne	Berne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Elimination half life in dependence of the degree of renal failure		0, 15, 30, 60, 180 minutes and 24 hours after application	No
Secondary	Changes in acid-base parameter after application of sodium thiosulfate		0, 15, 30, 60, 180 minutes and 24 hours after application	No