- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00375635
Removal of Protein Bound Uremic Toxins by Modified Plasma Separation and Adsorption Combined With Hemodialysis
September 12, 2006 updated by: Rigshospitalet, Denmark
Removal of Protein Bound Uremic Toxins in Chronic Hemodialysis Patients by Modified Plasma Separation and Adsorption Combined With Hemodialysis
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.
Study Overview
Detailed Description
Measurements of uremic protein bound substances before and after mFPSA and a preceding routine hemodialysis session.
Study Type
Interventional
Enrollment
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mette B Damholt, MD,Ph.d.
- Phone Number: 50589 +45 35453545
- Email: damholt@dadlnet.dk
Study Contact Backup
- Name: Soren D Ladefoged, MD
- Phone Number: 51020 +45 35453545
- Email: SOERENRH04736LADEFOGED@rh.dk
Study Locations
-
-
-
Copenhagen, Denmark, 2200
- Recruiting
- Rigshospitalet
-
Contact:
- Mette B Damholt, MD,Ph.d.
- Phone Number: +45 35450589
- Email: damholt@dadlnet.dk
-
Principal Investigator:
- Mette B Damholt, MD,Ph.d.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Over the age of 18
- Anuria
- Chronic hemodialysis dependence
Exclusion Criteria:
- No present history of bleeding episodes
- Cardiac diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Blood pressure
|
Safety serological parameters
|
Concentrations of protein bound uremic toxins
|
Secondary Outcome Measures
Outcome Measure |
---|
Bleeding episodes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mette B Damholt, MD,Ph.d., Rigshospitalet P2132
- Principal Investigator: Soren D Ladefoged, MD, Rigshospitalet, Denmark
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Study Completion
October 1, 2006
Study Registration Dates
First Submitted
September 12, 2006
First Submitted That Met QC Criteria
September 12, 2006
First Posted (Estimate)
September 13, 2006
Study Record Updates
Last Update Posted (Estimate)
September 13, 2006
Last Update Submitted That Met QC Criteria
September 12, 2006
Last Verified
September 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MBD2006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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