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

Primary Purpose

Uremia

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
mFPSA treatment
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Uremia focused on measuring mFPSA, Uremic toxins, Protein bound toxins, Uremia, Chronic hemodialysis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • No present history of bleeding episodes
  • Cardiac diseases

Sites / Locations

  • RigshospitaletRecruiting

Outcomes

Primary Outcome Measures

Blood pressure
Safety serological parameters
Concentrations of protein bound uremic toxins

Secondary Outcome Measures

Bleeding episodes

Full Information

First Posted
September 12, 2006
Last Updated
September 12, 2006
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT00375635
Brief Title
Removal of Protein Bound Uremic Toxins by Modified Plasma Separation and Adsorption Combined With Hemodialysis
Official Title
Removal of Protein Bound Uremic Toxins in Chronic Hemodialysis Patients by Modified Plasma Separation and Adsorption Combined With Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uremia
Keywords
mFPSA, Uremic toxins, Protein bound toxins, Uremia, Chronic hemodialysis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
mFPSA treatment
Primary Outcome Measure Information:
Title
Blood pressure
Title
Safety serological parameters
Title
Concentrations of protein bound uremic toxins
Secondary Outcome Measure Information:
Title
Bleeding episodes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Over the age of 18 Anuria Chronic hemodialysis dependence Exclusion Criteria: No present history of bleeding episodes Cardiac diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mette B Damholt, MD,Ph.d.
Phone
+45 35453545
Ext
50589
Email
damholt@dadlnet.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Soren D Ladefoged, MD
Phone
+45 35453545
Ext
51020
Email
SOERENRH04736LADEFOGED@rh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mette B Damholt, MD,Ph.d.
Organizational Affiliation
Rigshospitalet P2132
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Soren D Ladefoged, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mette B Damholt, MD,Ph.d.
Phone
+45 35450589
Email
damholt@dadlnet.dk
First Name & Middle Initial & Last Name & Degree
Mette B Damholt, MD,Ph.d.

12. IPD Sharing Statement

Learn more about this trial

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

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