The Pharmacologic Profile of Sodium Thiosulfate in Renal Failure and Healthy Volunteers
Primary Purpose
Renal Failure
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Sodium thiosulfate
Sponsored by
About this trial
This is an interventional treatment trial for Renal Failure focused on measuring renal failure, sodium Thiosulfate, pharmakokinetic
Eligibility Criteria
Inclusion Criteria:
- healthy volunteer or patient with renal failure
Exclusion Criteria:
- pregnancy
- withdrawal of consent
Sites / Locations
- Department of Nephrology and Hypertension, University of Berne
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
dialysis
healthy volunteer
Arm Description
Two doses of sodium thiosulfate
One dose of sodium thiosulfate
Outcomes
Primary Outcome Measures
Elimination half life in dependence of the degree of renal failure
Secondary Outcome Measures
Changes in acid-base parameter after application of sodium thiosulfate
Full Information
NCT ID
NCT01008631
First Posted
November 5, 2009
Last Updated
October 12, 2011
Sponsor
Insel Gruppe AG, University Hospital Bern
1. Study Identification
Unique Protocol Identification Number
NCT01008631
Brief Title
The Pharmacologic Profile of Sodium Thiosulfate in Renal Failure and Healthy Volunteers
Official Title
The Pharmacologic Profile of Sodium Thiosulfate in Renal Failure and Healthy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure
Keywords
renal failure, sodium Thiosulfate, pharmakokinetic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dialysis
Arm Type
Experimental
Arm Description
Two doses of sodium thiosulfate
Arm Title
healthy volunteer
Arm Type
Experimental
Arm Description
One dose of sodium thiosulfate
Intervention Type
Drug
Intervention Name(s)
Sodium thiosulfate
Other Intervention Name(s)
Na2S2O3
Intervention Description
6g of Sodium Thiosulfate are applicated in a short infusion over a time of 5 min
Primary Outcome Measure Information:
Title
Elimination half life in dependence of the degree of renal failure
Time Frame
0, 15, 30, 60, 180 minutes and 24 hours after application
Secondary Outcome Measure Information:
Title
Changes in acid-base parameter after application of sodium thiosulfate
Time Frame
0, 15, 30, 60, 180 minutes and 24 hours after application
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy volunteer or patient with renal failure
Exclusion Criteria:
pregnancy
withdrawal of consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Farese, MD
Organizational Affiliation
University of Berne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nephrology and Hypertension, University of Berne
City
Berne
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
21566113
Citation
Farese S, Stauffer E, Kalicki R, Hildebrandt T, Frey BM, Frey FJ, Uehlinger DE, Pasch A. Sodium thiosulfate pharmacokinetics in hemodialysis patients and healthy volunteers. Clin J Am Soc Nephrol. 2011 Jun;6(6):1447-55. doi: 10.2215/CJN.10241110. Epub 2011 May 12.
Results Reference
derived
Learn more about this trial
The Pharmacologic Profile of Sodium Thiosulfate in Renal Failure and Healthy Volunteers
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