Renal FailureNCT01008631
The Pharmacologic Profile of Sodium Thiosulfate in Renal Failure and Healthy Volunteers
A study testing Sodium thiosulfate in people with Renal Failure, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Failure
- What is being tested?
- Sodium thiosulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2009to Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteer or patient with renal failure
Who cannot join
- pregnancy
- withdrawal of consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Nephrology and Hypertension, University of Berne
Bern, Canton of Bern, 3010
About this study
Official title: The Pharmacologic Profile of Sodium Thiosulfate in Renal Failure and Healthy
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.
- Conditions
- Renal Failure
- Being tested
- Sodium thiosulfate
- Keywords
- renal failure, sodium Thiosulfate, pharmakokinetic
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium thiosulfateDrug
Also called Na2S2O3
6g of Sodium Thiosulfate are applicated in a short infusion over a time of 5 min
| Study group | Role | What they receive |
|---|---|---|
| dialysis | Experimental | Two doses of sodium thiosulfate Receives: Drug: Sodium thiosulfate |
| healthy volunteer | Experimental | One dose of sodium thiosulfate Receives: Drug: Sodium thiosulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elimination half life in dependence of the degree of renal failure
Measured: 0, 15, 30, 60, 180 minutes and 24 hours after application
Secondary outcomes (1)
Changes in acid-base parameter after application of sodium thiosulfate
Measured: 0, 15, 30, 60, 180 minutes and 24 hours after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2009 (estimated)
- Study startSep 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Investigators
- Stefan Farese, MD, Principal investigator, University of Berne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01008631
- Sponsor's protocol ID
- Uehlinger-002
- Status last verified
- Oct 2011
- First submitted
- 5 Nov 2009
- Last updated
- 13 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacologic Profile of Sodium Thiosulfate in Renal Failure and Healthy
- ClinicalTrials.gov ID
- NCT01008631
- Acronym / sponsor ID
- Uehlinger-002
- Conditions
- Renal Failure
- Keywords
- renal failure, sodium Thiosulfate, pharmakokinetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 6 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dialysis | Experimental | Drug: Sodium thiosulfateTwo doses of sodium thiosulfate |
| healthy volunteer | Experimental | Drug: Sodium thiosulfateOne dose of sodium thiosulfate |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy volunteer or patient with renal failure
Key exclusion criteria (2 listed)
- pregnancy
- withdrawal of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium thiosulfateAlso: Na2S2O36g of Sodium Thiosulfate are applicated in a short infusion over a time of 5 min | Drug | dialysis, healthy volunteer |
Primary outcome
Elimination half life in dependence of the degree of renal failure
Time frame: 0, 15, 30, 60, 180 minutes and 24 hours after application
1 secondary outcome
Changes in acid-base parameter after application of sodium thiosulfate
Time frame: 0, 15, 30, 60, 180 minutes and 24 hours after application
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2011.
- Derived from this study: PubMed 21566113Farese 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Farese, MD principal investigator
University of Berne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium thiosulfate in people with Renal Failure, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elimination half life in dependence of the degree of renal failure (time frame: 0, 15, 30, 60, 180 minutes and 24 hours after application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01008631, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2011.