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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:
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00262353
First received: December 4, 2005
Last updated: June 28, 2010
Last verified: June 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Elimination of Protein-bound Uremic Retention Solutes by Prometheus Artificial Hepatic System Versus Conventional Dialysis

Resource links provided by NLM:


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Raymond Vanholder, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00262353     History of Changes
Other Study ID Numbers: 2004/416
Study First Received: December 4, 2005
Last Updated: June 28, 2010
Health Authority: Belgium: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 19, 2014