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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. The completion date has passed and the status has not been verified in more than two years.
Verified September 2006 by Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00375635
First Posted: September 13, 2006
Last Update Posted: September 13, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rigshospitalet, Denmark
  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
Intervention Model: Crossover Assignment
Masking: None (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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00375635     History of Changes
Other Study ID Numbers: MBD2006
First Submitted: September 12, 2006
First Posted: September 13, 2006
Last Update Posted: September 13, 2006
Last Verified: September 2006

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

Additional relevant MeSH terms:
Uremia
Kidney Diseases
Urologic Diseases