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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Rigshospitalet, Denmark.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00375635
First received: September 12, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted
  Purpose

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.


Condition Intervention
Uremia
 Procedure: mFPSA treatment

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Removal of Protein Bound Uremic Toxins in Chronic Hemodialysis Patients by Modified Plasma Separation and Adsorption Combined With Hemodialysis

Resource links provided by NLM:

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Blood pressure
  • Safety serological parameters
  • Concentrations of protein bound uremic toxins

Secondary Outcome Measures:
  • Bleeding episodes

Estimated Enrollment: 10
Study Start Date: March 2006
Estimated Study Completion Date: October 2006
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Over the age of 18
  • Anuria
  • Chronic hemodialysis dependence

Exclusion Criteria:

  • No present history of bleeding episodes
  • Cardiac diseases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00375635

Contacts
Contact: Mette B Damholt, MD,Ph.d. +45 35453545 ext 50589 damholt@dadlnet.dk
Contact: Soren D Ladefoged, MD +45 35453545 ext 51020 SOERENRH04736LADEFOGED@rh.dk

Locations
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark, 2200
Contact: Mette B Damholt, MD,Ph.d.     +45 35450589     damholt@dadlnet.dk    
Principal Investigator: Mette B Damholt, MD,Ph.d.            
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Mette B Damholt, MD,Ph.d. Rigshospitalet P2132
Principal Investigator: Soren D Ladefoged, MD Rigshospitalet, Denmark
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00375635     History of Changes
Other Study ID Numbers: MBD2006
Study First Received: September 12, 2006
Last Updated: September 12, 2006
Health Authority: Denmark: Ethics Committee

Keywords provided by Rigshospitalet, Denmark:
mFPSA
Uremic toxins
Protein bound toxins
Uremia
Chronic hemodialysis

Additional relevant MeSH terms:
Uremia
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on June 18, 2013