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

Insel Gruppe AG, University Hospital Bern

Status: Completed

Conditions: Renal Failure

Treatments: Drug: Sodium thiosulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT01008631

Uehlinger-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy volunteer or patient with renal failure

Exclusion criteria

• pregnancy
• withdrawal of consent

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

dialysis

Experimental group

Description:

Two doses of sodium thiosulfate

Treatment:

Drug: Sodium thiosulfate

healthy volunteer

Experimental group

Description:

One dose of sodium thiosulfate

Treatment:

Drug: Sodium thiosulfate