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OpenTrials
Completed

NCT Number: NCT00974779

High-cutoff Hemodialyzer to Reduce Chronic Inflammation in Hemodialysis Patients

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Internal Medicine II, Martin-Luther-University Medical School

Halle, Saxony-Anhalt, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HCO1100 dialyzer

Device

Thrice weekly dialysis using the HCO1100 dialyzer for 4.5h, 2 weeks

Other names: Gambro HCO1100

regular dialysis polyamide

Device

Continuation of the regular hemodialysis using polyamide high-flux hemodialysers

Other names: Gambro Polyflux 11

Primary outcomes

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

    Time frame: 2 weeks

Secondary outcomes

  1. Serum albumin losses

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Martin-Luther-Universität Halle-Wittenberg

Other

Collaborators

  • Gambro Dialysatoren GmbH
  • KfH Kuratorium für Dialyse und Nierentransplantation e.V., Neu Isenburg, Germany

Registry information

Official study title

Application of the "High-cutoff (HCO1100)" Hemodialyzer to Reduce Chronic Inflammation in Hemodialysis Patients With Elevated CRP Levels

Acronym: HCO1100

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 10, 2009
Registry last updated
Jan 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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