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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00974779
Recruitment Status : Completed
First Posted : September 10, 2009
Last Update Posted : January 18, 2012
Gambro Dialysatoren GmbH
KfH Kuratorium für Dialyse und Nierentransplantation e.V., Neu Isenburg, Germany
Information provided by (Responsible Party):
Matthias Girndt, Martin-Luther-Universität Halle-Wittenberg

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
End Stage Renal Disease 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 Type : Interventional  (Clinical Trial)
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 : November 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
U.S. FDA Resources

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 Name: 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 Name: Gambro Polyflux 11

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

Secondary Outcome Measures :
  1. Serum albumin losses [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00974779

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Matthias Girndt, Professor of Internal Medicine, Martin-Luther-Universität Halle-Wittenberg Identifier: NCT00974779     History of Changes
Other Study ID Numbers: KIM2H-2009-02
First Posted: September 10, 2009    Key Record Dates
Last Update Posted: January 18, 2012
Last Verified: January 2012

Keywords provided by Matthias Girndt, Martin-Luther-Universität Halle-Wittenberg:
kidney failure chronic
renal dialysis
end stage renal disease on regular thrice weekly hemodialysis

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