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

This study has been completed.
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 Identifier:
First received: September 9, 2009
Last updated: January 13, 2012
Last verified: January 2012
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 Intervention Phase
End Stage Renal Disease Device: HCO1100 dialyzer Device: regular dialysis polyamide Phase 2 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Matthias Girndt, Martin-Luther-Universität Halle-Wittenberg:

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

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

Enrollment: 19
Study Start Date: November 2009
Study Completion Date: December 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

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
Study First Received: September 9, 2009
Last Updated: January 13, 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
Renal Insufficiency, Chronic
Pathologic Processes
Urologic Diseases
Renal Insufficiency processed this record on August 17, 2017