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

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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

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.

Condition or disease Intervention/treatment Phase
Renal Failure Drug: Sodium thiosulfate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Pharmacologic Profile of Sodium Thiosulfate in Renal Failure and Healthy
Study Start Date : September 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: dialysis
Two doses of sodium thiosulfate
Drug: Sodium thiosulfate
6g of Sodium Thiosulfate are applicated in a short infusion over a time of 5 min
Other Name: Na2S2O3

Experimental: healthy volunteer
One dose of sodium thiosulfate
Drug: Sodium thiosulfate
6g of Sodium Thiosulfate are applicated in a short infusion over a time of 5 min
Other Name: Na2S2O3




Primary Outcome Measures :
  1. 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 Measures :
  1. Changes in acid-base parameter after application of sodium thiosulfate [ Time Frame: 0, 15, 30, 60, 180 minutes and 24 hours after application ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteer or patient with renal failure

Exclusion Criteria:

  • pregnancy
  • withdrawal of consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01008631


Locations
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Switzerland
Department of Nephrology and Hypertension, University of Berne
Berne, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Stefan Farese, MD University of Berne
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Stefan Farese, Department of nephrology and hypertension, University of Berne, University of Berne
ClinicalTrials.gov Identifier: NCT01008631    
Other Study ID Numbers: Uehlinger-002
First Posted: November 6, 2009    Key Record Dates
Last Update Posted: October 13, 2011
Last Verified: October 2011
Keywords provided by University Hospital Inselspital, Berne:
renal failure
sodium Thiosulfate
pharmakokinetic
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Sodium thiosulfate
Antidotes
Protective Agents
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Chelating Agents
Sequestering Agents