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

January 13, 2012 updated by: Matthias Girndt, Martin-Luther-Universität Halle-Wittenberg

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

19

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Sachsen-Anhalt
      • Halle (Saale), Sachsen-Anhalt, Germany
        • Department of Internal Medicine II, Martin-Luther-University Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Inflammation: CRP plasma level and quantity of circulating CD14/16 positive monocytes
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum albumin losses
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Martin-Luther-Universität Halle-Wittenberg

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

September 9, 2009

First Submitted That Met QC Criteria

September 9, 2009

First Posted (Estimate)

September 10, 2009

Study Record Updates

Last Update Posted (Estimate)

January 18, 2012

Last Update Submitted That Met QC Criteria

January 13, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KIM2H-2009-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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