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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
Information provided by:
Rigshospitalet, Denmark Identifier:
First received: September 12, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted
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
Procedure: mFPSA treatment

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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:

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.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • No present history of bleeding episodes
  • Cardiac diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00375635

Contact: Mette B Damholt, MD,Ph.d. +45 35453545 ext 50589
Contact: Soren D Ladefoged, MD +45 35453545 ext 51020

Rigshospitalet Recruiting
Copenhagen, Denmark, 2200
Contact: Mette B Damholt, MD,Ph.d.    +45 35450589   
Principal Investigator: Mette B Damholt, MD,Ph.d.         
Sponsors and Collaborators
Rigshospitalet, Denmark
Principal Investigator: Mette B Damholt, MD,Ph.d. Rigshospitalet P2132
Principal Investigator: Soren D Ladefoged, MD Rigshospitalet, Denmark
  More Information Identifier: NCT00375635     History of Changes
Other Study ID Numbers: MBD2006
Study First Received: September 12, 2006
Last Updated: September 12, 2006

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

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases processed this record on May 25, 2017