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NCT00262353 Clinical Trial

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

Renal Failure, Chronic Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00262353
Other study ID # 2004/416
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated

Study information
Verified date July 2021
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Stable patients - At least 3 months on dialysis - Arterio-venous fistula Exclusion Criteria: - Diabetic patients - Malignancies - Acute illnesses

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Dialysis with different artificial devices

Locations
Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Determination of the concentration of protein-bound toxins after treatment with different artificial devices
Secondary Determination of the kinetics of protein-bound toxins after treatment with different artificial devices
See also
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