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

This study is currently recruiting participants.

Verified by University Hospital, Ghent, December 2007

Sponsored by:	University Hospital, Ghent
Information provided by:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT00262353

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

MedlinePlus related topics: Kidney Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
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:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00262353

Contacts

Contact: Natalie Meert, MSc

0032/(0)9/240.45.20

natalie.meert@UGent.be

Locations

Belgium
University Hospital Ghent	Recruiting
Ghent, Belgium, 9000
Contact: Natalie Meert, MSc 0032/(0)9/240.45.20 natalie.meert@UGent.be
Sub-Investigator: Natalie Meert, MSc

Sponsors and Collaborators

University Hospital, Ghent

Investigators

Principal Investigator:

Raymond Vanholder, MD, PhD

University Hospital, Ghent

More Information

Website of the University Hospital Ghent This link exits the ClinicalTrials.gov site

Study ID Numbers:	2004/416
Study First Received:	December 4, 2005
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00262353
Health Authority:	Belgium: Institutional Review Board

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic

Kidney Diseases
Urinary Retention
Kidney Failure

ClinicalTrials.gov processed this record on January 16, 2009