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Albumin Dialysis in End-Stage Renal Disease: Detoxification Capacity and Impact on Vascular Endothelial Function

Phase 1 Study of Albumin Dialysis Using Prometheus in End Stage Renal Disease: Detoxification Capacity and Impact on Vascular Endothelial Function

Status
Suspended
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00442299
Enrollment
10
Registered
2007-03-01
Start date
2005-04-30
Completion date
2009-12-31
Last updated
2007-03-01

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

Conditions

Chronic Kidney Disease

Keywords

hemodialysis, urmeic retention solute, biocompatibility

Brief summary

The uremic syndrome is mainly related to the retention of a host of compounds, due to altered glomerular filtration and other factors of renal dysfunction, e.g. tubular secretion. Uremic retention solutes are arbitrarily subdivided in three different categories according to their physicochemical characteristics and their subsequent behaviour during dialysis: (i) the small, water-soluble, non-protein bound compounds, (ii) the larger middle molecules, mainly peptides and (iii) the small protein-bound compounds (1). Although direct proof is lacking, several lines of evidence indicate that albumin is the most important carrier protein. Removal of protein bound uremic retention solutes is limited. The Prometheus® system fractionates blood into plasma and cellular components, using an albumin-permeable polysulfon filter (AlbuFlow®) with a specially designed sieving coefficient curve (1.0 for 2-microglobulin, \>0.6 for albumin, \<0.3 for IgG, \<0.1 for fibrinogen and \<0.01 for IgM). Due to the high sieving coefficient of the filter for large molecules (i.e. cut-off at about 250 kD) molecules up to the size of albumin (69 kD) easily pass from blood into the secondary circuit which is filled with isotonic sodium chloride solution, whereas larger molecules like fibrinogen (340 kD) cannot pass through the filter. In the secondary circuit the filtered plasma with the albumin-bound toxins flows through one or two adsorbers in a row with maximized adsorption capacity for putative liver toxins that are directly adsorbed ('fractionated plasma separation and adsorption' or FPSA). The purified plasma is then returned to the blood side of the albumin filter. In order to eliminate water-soluble toxins, blood thereafter undergoes hemodialysis using a conventional high-flux dialyser. We hypothesise that removal of protein bound uremic retention solutes can be improved by FPSA as compared to standard hemodialysis.

Interventions

DEVICEFractionated Plasma Separation and Adsorption (FPSA)

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* \> 18 years of age * maintenance (\> 3 months) hemodialysis patient * Stable access, blood flow at least 250 mL/min

Exclusion criteria

* Known hemodialysis-related hypotension

Design outcomes

Primary

MeasureTime frame
Uremic retention solute reduction rate
Biocompatibility

Countries

Belgium

Outcome results

None listed

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