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NCT00375635 Clinical Trial

Removal of Protein Bound Uremic Toxins by Modified Plasma Separation and Adsorption Combined With Hemodialysis

Uremia Clinical Trial

Official title:
Removal of Protein Bound Uremic Toxins in Chronic Hemodialysis Patients by Modified Plasma Separation and Adsorption Combined With Hemodialysis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00375635
Other study ID # MBD2006
Secondary ID
Status Recruiting
Phase N/A
First received September 12, 2006
Last updated September 12, 2006
Start date March 2006
Est. completion date October 2006

Study information
Verified date September 2006
Source Rigshospitalet, Denmark
Contact Mette B Damholt, MD,Ph.d.
Phone +45 35453545
Email damholt@dadlnet.dk
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Interventional

Clinical Trial Summary

The aim of this study is to examine removal of protein bound uremic substances by mFPSA in chronic hemodialysis patients. mFPSA is an extracorporal blood purification system developed for detoxification in acute liver failure by removal of protein bound as well as water soluble substances.

Description:

Measurements of uremic protein bound substances before and after mFPSA and a preceding routine hemodialysis session.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date October 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Over the age of 18

- Anuria

- Chronic hemodialysis dependence

Exclusion Criteria:

- No present history of bleeding episodes

- Cardiac diseases

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Procedure:
• mFPSA treatment

Locations
Country Name City State
Denmark Rigshospitalet Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood pressure
Primary Safety serological parameters
Primary Concentrations of protein bound uremic toxins
Secondary Bleeding episodes
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