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

NCT ID: NCT01008631

Last Updated: 2011-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-08-31

Brief Summary

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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

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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.

Conditions

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Renal Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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dialysis

Two doses of sodium thiosulfate

Group Type EXPERIMENTAL

Sodium thiosulfate

Intervention Type DRUG

6g of Sodium Thiosulfate are applicated in a short infusion over a time of 5 min

healthy volunteer

One dose of sodium thiosulfate

Group Type EXPERIMENTAL

Sodium thiosulfate

Intervention Type DRUG

6g of Sodium Thiosulfate are applicated in a short infusion over a time of 5 min

Interventions

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Sodium thiosulfate

6g of Sodium Thiosulfate are applicated in a short infusion over a time of 5 min

Intervention Type DRUG

Other Intervention Names

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Na2S2O3

Eligibility Criteria

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Inclusion Criteria

* healthy volunteer or patient with renal failure

Exclusion Criteria

* pregnancy
* withdrawal of consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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University of Berne

Principal Investigators

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Stefan Farese, MD

Role: PRINCIPAL_INVESTIGATOR

University of Berne

Locations

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Department of Nephrology and Hypertension, University of Berne

Bern, Canton of Bern, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 21566113 (View on PubMed)

Other Identifiers

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Uehlinger-002

Identifier Type: -

Identifier Source: org_study_id