Skip to main content
OpenTrials
Completed

NCT Number: NCT01008631

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

The pharmacokinetics of sodium thiosulfate in humans with different degrees of renal failure and in healthy volunteers will be after two single shot applications.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Renal Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nephrology and Hypertension, University of Berne

Bern, Canton of Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy volunteer or patient with renal failure

Exclusion criteria

  • pregnancy
  • withdrawal of consent

Treatment and study plan

Sodium thiosulfate

Drug

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

Other names: Na2S2O3

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

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

The Pharmacologic Profile of Sodium Thiosulfate in Renal Failure and Healthy

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 6, 2009
Registry last updated
Oct 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.