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

This study has suspended participant recruitment.
(Major side-effects)
Sponsor:
Information provided by:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT00442299
First received: February 28, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
Device: Fractionated Plasma Separation and Adsorption (FPSA)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of Albumin Dialysis Using Prometheus in End Stage Renal Disease: Detoxification Capacity and Impact on Vascular Endothelial Function

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Uremic retention solute reduction rate
  • Biocompatibility

Estimated Enrollment: 10
Study Start Date: April 2005
Estimated Study Completion Date: December 2009
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442299

Locations
Belgium
Universitaire Ziekenhuizen Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Study Director: Pieter Evenepoel, MD UZ Leuven
Principal Investigator: Kathleen Claes, MD UZ Leuven
Principal Investigator: Björn Meijers, MD UZ Leuven
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00442299     History of Changes
Other Study ID Numbers: ML3041
Study First Received: February 28, 2007
Last Updated: February 28, 2007
Health Authority: Belgium: Institutional Review Board

Keywords provided by Universitaire Ziekenhuizen Leuven:
hemodialysis, urmeic retention solute, biocompatibility

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on September 22, 2014