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HCO1100: High-cutoff Hemodialyzer to Reduce Chronic Inflammation in Hemodialysis Patients

Sponsor
Martin-Luther-Universität Halle-Wittenberg (Other)
Overall Status
Completed
CT.gov ID
NCT00974779
Collaborator
Gambro Dialysatoren GmbH (Industry), KfH Kuratorium für Dialyse und Nierentransplantation e.V., Neu Isenburg, Germany (Other)
19
Enrollment
1
Location
2
Arms
25
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to test whether a dialyzer with a higher than usual permeability for proteins can eliminate proinflammatory proteins from the blood of patients on regular maintenance hemodialysis who have chronically elevated levels of inflammation markers such as C-reactive protein (CRP) in their blood.

Condition or Disease Intervention/Treatment Phase
  • Device: HCO1100 dialyzer
  • Device: regular dialysis polyamide
 Phase 2/Phase 3

Detailed Description

Patients with ESRD on chronic hemodialysis patients frequently have elevated markers of inflammation (e.g. serum CRP values). Hemodialysis may clear the blood from low molecular weight toxins and retention products such as creatinine, potassium, or urea. The dialyzer clearance of middle to high molecular weight substances such as cytokines and cytokine receptors is low. Nearly 50% of chronic dialysis patients have persistent subclinical inflammation which is strongly associated with cardiovascular disease and mortality. The study tests the hypothesis that removal of proteins in the weight range of 10.000-30.000 D via a more permeable dialyzer membrane reduces chronic inflammation in these patients.

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Application of the "High-cutoff (HCO1100)" Hemodialyzer to Reduce Chronic Inflammation in Hemodialysis Patients With Elevated CRP Levels
Study Start Date :
Nov 1, 2009
Actual Primary Completion Date :
Aug 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: HCO dialyzer

Hemodialysis with the HCO1100 hemodialyzer membrane with high molecular weight cut off.

Device: HCO1100 dialyzer
Thrice weekly dialysis using the HCO1100 dialyzer for 4.5h, 2 weeks
Other Names:
  • Gambro HCO1100

    		•
    Active Comparator: Placebo

    Regular dialysis using a polyamide high-flux hemodialyzer

    Device: regular dialysis polyamide
    Continuation of the regular hemodialysis using polyamide high-flux hemodialysers
    Other Names:
  • Gambro Polyflux 11

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Inflammation: CRP plasma level and quantity of circulating CD14/16 positive monocytes [2 weeks]

    Secondary Outcome Measures

    1. Serum albumin losses [2 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • regular hemodialysis for at least 3 months

    • treatment thrice weekly

    • high-flux hemodialyzer for at least 4 weeks

    • age > 18 years and < 80 years

    • at least one CRP value > 5mg/L within 8 weeks before inclusion

    • able to understand and consent the study

    • written informed consent

    Exclusion Criteria:

    • no consent

    • clinically apparent acute infection

    • CRP > 50 mg/L

    • serum albumin < 3,5 mg/L

    • central venous line as dialysis access

    • immunosuppressive medication

    • pregnancy or lactation

    • inclusion into any other interventional trial

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Internal Medicine II, Martin-Luther-University Medical School Halle (Saale) Sachsen-Anhalt Germany

    Sponsors and Collaborators

    • Martin-Luther-Universität Halle-Wittenberg
    • Gambro Dialysatoren GmbH
    • KfH Kuratorium für Dialyse und Nierentransplantation e.V., Neu Isenburg, Germany

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Matthias Girndt, Professor of Internal Medicine, Martin-Luther-Universität Halle-Wittenberg
    ClinicalTrials.gov Identifier:
    NCT00974779
    Other Study ID Numbers:
    • KIM2H-2009-02
    First Posted:
    Sep 10, 2009
    Last Update Posted:
    Jan 18, 2012
    Last Verified:
    Jan 1, 2012
    Keywords provided by Matthias Girndt, Professor of Internal Medicine, Martin-Luther-Universität Halle-Wittenberg
    kidney failure chronic
    renal dialysis
    inflammation
    monocytes
    end stage renal disease on regular thrice weekly hemodialysis
    Additional relevant MeSH terms:
    Kidney Diseases
    Kidney Failure, Chronic
    Inflammation

    Study Results

    No Results Posted as of Jan 18, 2012