Back to resultsElimination of Protein-bound Uremic Retention Solutes by Prometheus Artificial Hepatic System Versus Conventional Dialysis
Primary Purpose
Renal Failure, Chronic
Status
Withdrawn
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Dialysis with different artificial devices
Sponsored by
About this trial
This is an interventional treatment trial for Renal Failure, Chronic
Eligibility Criteria
Inclusion Criteria: Stable patients At least 3 months on dialysis Arterio-venous fistula Exclusion Criteria: Diabetic patients Malignancies Acute illnesses
Sites / Locations
- University Hospital Ghent
Outcomes
Primary Outcome Measures
Determination of the concentration of protein-bound toxins after treatment with different artificial devices
Secondary Outcome Measures
Determination of the kinetics of protein-bound toxins after treatment with different artificial devices
Full Information
NCT ID
NCT00262353
First Posted
December 4, 2005
Last Updated
July 1, 2021
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT00262353
Brief Title
Elimination of Protein-bound Uremic Retention Solutes by Prometheus Artificial Hepatic System Versus Conventional Dialysis
Official Title
Elimination of Protein-bound Uremic Retention Solutes by Prometheus Artificial Hepatic System Versus Conventional Dialysis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Withdrawn
Why Stopped
study never started because of safety alerts in literature regarding the topic to be examined
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparison of the efficacy of dialysis by conventional dialysis versus Prometheus artificial hepatic system
Detailed Description
After inclusion, patients will be dialysed with low-flux artificial kidneys. 1 week of dialysis exists of 3 days of dialysis. In week 4, day 2, patients will be treated once with the Prometheus artificial hepatic system or with high-flux dialysis. The other days low-flux kidneys will be used. Week 5 and 6 are a wash-out period. Week 7 is identical to week 4 but the other system than in week 4 is used. Blood samples are taken at regular moments in week 3, week 4 (day 2) and week 7 (day 2).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Dialysis with different artificial devices
Primary Outcome Measure Information:
Title
Determination of the concentration of protein-bound toxins after treatment with different artificial devices
Secondary Outcome Measure Information:
Title
Determination of the kinetics of protein-bound toxins after treatment with different artificial devices
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stable patients
At least 3 months on dialysis
Arterio-venous fistula
Exclusion Criteria:
Diabetic patients
Malignancies
Acute illnesses
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Vanholder, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Website of the University Hospital Ghent
Learn more about this trial
Elimination of Protein-bound Uremic Retention Solutes by Prometheus Artificial Hepatic System Versus Conventional Dialysis
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