Chronic Kidney Disease Clinical Trial
Official title:
Phase 1 Study of Albumin Dialysis Using Prometheus in End Stage Renal Disease: Detoxification Capacity and Impact on Vascular Endothelial Function
Verified date | February 2007 |
Source | Universitaire Ziekenhuizen Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Suspended |
Enrollment | 10 |
Est. completion date | December 2009 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Universitaire Ziekenhuizen Leuven | Leuven | Vlaams-Brabant |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen Leuven |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Uremic retention solute reduction rate | |||
Primary | Biocompatibility |
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