CClinicalTrials.gg
CompletedNCT01008631Updated Oct 13, 2011

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

An interventional study of Sodium thiosulfate in Renal Failure, sponsored by Insel Gruppe AG, University Hospital Bern. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-10-13.

Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Non-randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Renal Failure

Browse trials for

Keywords

  • renal failure
  • sodium Thiosulfate
  • pharmakokinetic
03

In context

Renal Insufficiency

1,994 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 19 is below the median of 43 across 1,503 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy volunteer or patient with renal failure

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • withdrawal of consent
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    dialysis

    Two doses of sodium thiosulfate

    Drug: Sodium thiosulfate

  • Experimental
    healthy volunteer

    One dose of sodium thiosulfate

    Drug: Sodium thiosulfate

Interventions

  • DrugSodium thiosulfate

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

    Also known as: Na2S2O3

06

What researchers measure

Primary outcomes

  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 outcomes

  1. Changes in acid-base parameter after application of sodium thiosulfate

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

07

Study locations

1 site
  • Department of Nephrology and Hypertension, University of Berne
    Berne, 3010, Switzerland
08

References and documents

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. doi: 10.2215/CJN.10241110. Epub 2011 May 12. PubMed 21566113 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 13, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01008631
Lead sponsor
Insel Gruppe AG, University Hospital Bern
First posted
Nov 6, 2009
Start date
Sep 2009
Primary completion
Aug 2010
Completion
Aug 2010
Last update
Oct 13, 2011

Study contacts

Stefan Farese, MD
principal investigator · University of Berne

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion