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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01008631
Recruitment Status : Completed
First Posted : November 6, 2009
Last Update Posted : October 13, 2011
Sponsor:
Information provided by:
University Hospital Inselspital, Berne

Tracking Information
First Submitted Date  ICMJE November 5, 2009
First Posted Date  ICMJE November 6, 2009
Last Update Posted Date October 13, 2011
Study Start Date  ICMJE September 2009
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2009)
Elimination half life in dependence of the degree of renal failure [ Time Frame: 0, 15, 30, 60, 180 minutes and 24 hours after application ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2009)
Changes in acid-base parameter after application of sodium thiosulfate [ Time Frame: 0, 15, 30, 60, 180 minutes and 24 hours after application ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Pharmacologic Profile of Sodium Thiosulfate in Renal Failure and Healthy Volunteers
Official Title  ICMJE The Pharmacologic Profile of Sodium Thiosulfate in Renal Failure and Healthy
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Renal Failure
Intervention  ICMJE Drug: Sodium thiosulfate
6g of Sodium Thiosulfate are applicated in a short infusion over a time of 5 min
Other Name: Na2S2O3
Study Arms  ICMJE
  • Experimental: dialysis
    Two doses of sodium thiosulfate
    Intervention: Drug: Sodium thiosulfate
  • Experimental: healthy volunteer
    One dose of sodium thiosulfate
    Intervention: Drug: Sodium thiosulfate
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 12, 2011)
19
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2009)
24
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy volunteer or patient with renal failure

Exclusion Criteria:

  • pregnancy
  • withdrawal of consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01008631
Other Study ID Numbers  ICMJE Uehlinger-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stefan Farese, Department of nephrology and hypertension, University of Berne, University of Berne
Study Sponsor  ICMJE University Hospital Inselspital, Berne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stefan Farese, MD University of Berne
PRS Account University Hospital Inselspital, Berne
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP