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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00262353

Enrollment

Registered

2005-12-06

Start date

Unknown

Completion date

Unknown

Last updated

2021-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Failure, Chronic

Brief summary

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

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).

Interventions

DEVICEDialysis with different artificial devices

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Diabetic patients * Malignancies * Acute illnesses

Design outcomes

Primary

Measure	Time frame
Determination of the concentration of protein-bound toxins after treatment with different artificial devices	—

Secondary

Measure	Time frame
Determination of the kinetics of protein-bound toxins after treatment with different artificial devices	—

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026