The Pharmacologic Profile of Sodium Thiosulfate in Renal... | NCT01008631

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

NCT01008631

Sponsor

Insel Gruppe AG, University Hospital Bern

Status

Completed

Last Update Posted

Oct 13, 2011Estimated

Enrollment

19Actual

Phase

Not Applicable

Conditions

Renal Failure

Interventions

Sodium thiosulfate

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Aug 2010Actual

Completion Date

Aug 2010Actual

First Submitted Date

Nov 5, 2009

First Submission Date that Met QC Criteria

Nov 5, 2009

First Posted Date

Nov 6, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2011

Last Update Posted Date

Oct 13, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
dialysis	Experimental	Two doses of sodium thiosulfate	Drug: Sodium thiosulfate
healthy volunteer	Experimental	One dose of sodium thiosulfate	Drug: Sodium thiosulfate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sodium thiosulfate	Drug	6g of Sodium Thiosulfate are applicated in a short infusion over a time of 5 min	dialysis healthy volunteer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Elimination half life in dependence of the degree of renal failure		0, 15, 30, 60, 180 minutes and 24 hours after application

Secondary Outcomes

Measure	Description	Time Frame
Changes in acid-base parameter after application of sodium thiosulfate		0, 15, 30, 60, 180 minutes and 24 hours after application

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy volunteer or patient with renal failure

Exclusion Criteria:

pregnancy
withdrawal of consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stefan Farese, MD	University of Berne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Nephrology and Hypertension, University of Berne		Bern	Canton of Bern	3010	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21566113	Derived	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.

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications