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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
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Failure focused on measuring renal failure, sodium Thiosulfate, pharmakokinetic

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
November 5, 2009
Last Updated
October 12, 2011
Sponsor
Insel Gruppe AG, University Hospital Bern
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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

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

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