Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01008631
Other study ID # Uehlinger-002
Secondary ID
Status Completed
Phase N/A
First received November 5, 2009
Last updated October 12, 2011
Start date September 2009
Est. completion date August 2010

Study information

Verified date October 2011
Source University Hospital Inselspital, Berne
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- healthy volunteer or patient with renal failure

Exclusion Criteria:

- pregnancy

- withdrawal of consent

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Switzerland Department of Nephrology and Hypertension, University of Berne Berne

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Elimination half life in dependence of the degree of renal failure 0, 15, 30, 60, 180 minutes and 24 hours after application No
Secondary Changes in acid-base parameter after application of sodium thiosulfate 0, 15, 30, 60, 180 minutes and 24 hours after application No
See also
  Status Clinical Trial Phase
Completed NCT02763410 - Impact of the Composition of Packed Red Blood Cell Supernatant on Renal Dysfunction and Posttransfusion Immunomodulation
Active, not recruiting NCT03183245 - Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis Phase 3
Completed NCT04084301 - Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation, Blood Flow and Tubular Injury N/A
Completed NCT03292029 - Pilot Medical Evaluation of the T50 Test N/A
Suspended NCT04589065 - SCD for CRS in Congestive Heart Failure (CHF) (No Left Ventricular Assist Device) N/A
Completed NCT03806998 - Effects of a Ketoacid Supplementation in Patients With Stage III to IV Renal Failure Phase 3
Active, not recruiting NCT03672110 - Slow and Low Start of a Tacrolimus Once Daily Immunosuppressive Regimen Phase 3
Completed NCT02325726 - RRI Compared With NephroCheckTM to Predict Acute Renal Failure After Cardiac Surgery. N/A
Completed NCT02116270 - Accelerated Immunosenescence and Chronic Kidney Disease N/A
Completed NCT01388270 - Effect of a Pre Heparin Coated Dialysis Filter on Coagulation During Hemodialysis Phase 4
Completed NCT01859273 - Adherence Enhancement for Renal Transplant Patients N/A
Completed NCT00966615 - The Effect of Neutral Peritoneal Dialysis (PD) Solution With Minimal Glucose-Degradation-Product (GDP) on Fluid Status and Body Composition Phase 4
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Completed NCT01187953 - Double-Blind,Double-Dummy,Efficacy/Safety,LCP-Tacroâ„¢ Vs Prograf®,Prevention Rejection,De Novo Adult Kidney Tx Phase 3
Completed NCT00765661 - Pharmacokinetics of LCP-Tacro(TM) Once Daily And Prograf® Twice A Day in Adult De Novo Kidney Transplant Patients Phase 2
Completed NCT00737672 - GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis Phase 3
Completed NCT00808691 - Microcirculation and Oxidative Stress in Critical Ill Patients in Surgical Intensive Care Unit N/A
Recruiting NCT00470769 - The Efficacy of Color-Doppler Ultrasonography to Assess the Renal Blood Flow With the Estimation of GFR N/A
Terminated NCT00338455 - Natrecor (Nesiritide) in Transplant-Eligible Management of Congestive Heart Failure-TMAC Phase 2
Completed NCT03917186 - Desflurane vs. Sevoflurane in Endovascular Aortic Repair Phase 4