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Elimination of Protein-bound Uremic Retention Solutes by Prometheus Artificial Hepatic System Versus Conventional Dialysis

This study has suspended participant recruitment.
(study never started because of safety alerts in literature regarding the topic to be examined)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00262353
First Posted: December 6, 2005
Last Update Posted: June 29, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Ghent
  Purpose
Comparison of the efficacy of dialysis by conventional dialysis versus Prometheus artificial hepatic system

Condition Intervention
Renal Failure, Chronic Device: Dialysis with different artificial devices

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Elimination of Protein-bound Uremic Retention Solutes by Prometheus Artificial Hepatic System Versus Conventional Dialysis

Further study details as provided by University Hospital, Ghent:

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

Estimated Enrollment: 10
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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stable patients
  • At least 3 months on dialysis
  • Arterio-venous fistula

Exclusion Criteria:

  • Diabetic patients
  • Malignancies
  • Acute illnesses
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00262353


Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Raymond Vanholder, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
Responsible Party: Raymond Vanholder, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00262353     History of Changes
Other Study ID Numbers: 2004/416
First Submitted: December 4, 2005
First Posted: December 6, 2005
Last Update Posted: June 29, 2010
Last Verified: June 2010

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic