The Pharmacologic Profile of Sodium Thiosulfate in Renal Failure and Healthy Volunteers
This study has been completed.
Sponsor:
University Hospital Inselspital, Berne
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01008631
First received: November 5, 2009
Last updated: October 12, 2011
Last verified: October 2011
| Tracking Information | |||||
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| First Received Date ICMJE | November 5, 2009 | ||||
| Last Updated Date | October 12, 2011 | ||||
| Start Date ICMJE | September 2009 | ||||
| Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Elimination half life in dependence of the degree of renal failure [ Time Frame: 0, 15, 30, 60, 180 minutes and 24 hours after application ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01008631 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Changes in acid-base parameter after application of sodium thiosulfate [ Time Frame: 0, 15, 30, 60, 180 minutes and 24 hours after application ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | 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. |
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| 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 ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| 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 |
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| Study Arm (s) |
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| 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. Epub 2011 May 12. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 19 | ||||
| Completion Date | August 2010 | ||||
| Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 90 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Switzerland | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01008631 | ||||
| Other Study ID Numbers ICMJE | Uehlinger-002 | ||||
| Has Data Monitoring Committee | Yes | ||||
| 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 |
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| Information Provided By | University Hospital Inselspital, Berne | ||||
| Verification Date | October 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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