NCT01008631

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

October 13, 2011

Status Verified

October 1, 2011

Enrollment Period

11 months

First QC Date

November 5, 2009

Last Update Submit

October 12, 2011

Conditions

Renal Failure

Keywords

renal failuresodium Thiosulfatepharmakokinetic

Outcome Measures

Primary Outcomes (1)

  • Elimination half life in dependence of the degree of renal failure

    0, 15, 30, 60, 180 minutes and 24 hours after application

Secondary Outcomes (1)

  • Changes in acid-base parameter after application of sodium thiosulfate

    0, 15, 30, 60, 180 minutes and 24 hours after application

Study Arms (2)

dialysis

EXPERIMENTAL

Two doses of sodium thiosulfate

Drug: Sodium thiosulfate

healthy volunteer

EXPERIMENTAL

One dose of sodium thiosulfate

Drug: Sodium thiosulfate

Interventions

Sodium thiosulfateDRUG

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

Also known as: Na2S2O3
dialysishealthy volunteer

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy volunteer or patient with renal failure

You may not qualify if:

  • pregnancy
  • withdrawal of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nephrology and Hypertension, University of Berne

Bern, Canton of Bern, 3010, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 21566113DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Interventions

sodium thiosulfate

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Stefan Farese, MD

    University of Berne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 5, 2009

First Posted

November 6, 2009

Study Start

September 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

October 13, 2011

Record last verified: 2011-10

Locations

CH(1)