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

Tracking Information

First Received Date ^ICMJE

September 12, 2006

Last Updated Date

September 12, 2006

Start Date ^ICMJE

March 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Blood pressure
Safety serological parameters
Concentrations of protein bound uremic toxins

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Bleeding episodes

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

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

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Uremia

Intervention ^ICMJE

Procedure: mFPSA treatment

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

October 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Over the age of 18
Anuria
Chronic hemodialysis dependence

Exclusion Criteria:

No present history of bleeding episodes
Cardiac diseases

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT00375635

Other Study ID Numbers ^ICMJE

MBD2006

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Rigshospitalet, Denmark

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Mette B Damholt, MD,Ph.d.	Rigshospitalet P2132
Principal Investigator:	Soren D Ladefoged, MD	Rigshospitalet, Denmark

Information Provided By

Rigshospitalet, Denmark

Verification Date

September 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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