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

This study is currently recruiting participants.

Verified by Rigshospitalet, Denmark, September 2006

First Received: September 12, 2006 No Changes Posted

Sponsored by:	Rigshospitalet, Denmark
Information provided by:	Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00375635

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:	Diagnostic, Non-Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
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 Kidney Failure

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

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

Keywords provided by Rigshospitalet, Denmark:

mFPSA
Uremic toxins
Protein bound toxins
Uremia
Chronic hemodialysis

Study placed in the following topic categories:

Urologic Diseases
Uremia
Kidney Diseases

Additional relevant MeSH terms:

Urologic Diseases
Uremia
Kidney Diseases

ClinicalTrials.gov processed this record on September 10, 2009