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

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ClinicalTrials.gov Identifier: NCT00262353
Recruitment Status : Suspended (study never started because of safety alerts in literature regarding the topic to be examined)
First Posted : December 6, 2005
Last Update Posted : June 29, 2010
Sponsor:
Information provided by:
University Hospital, Ghent

Brief Summary:
Comparison of the efficacy of dialysis by conventional dialysis versus Prometheus artificial hepatic system

Condition or disease Intervention/treatment Phase
Renal Failure, Chronic Device: Dialysis with different artificial devices Not Applicable

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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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



Primary Outcome Measures :
  1. Determination of the concentration of protein-bound toxins after treatment with different artificial devices

Secondary Outcome Measures :
  1. Determination of the kinetics of protein-bound toxins after treatment with different artificial devices


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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

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

Additional Information:
Responsible Party: Raymond Vanholder, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00262353     History of Changes
Other Study ID Numbers: 2004/416
First Posted: December 6, 2005    Key Record Dates
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