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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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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 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Germany
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fiedler R, Neugebauer F, Ulrich C, Wienke A, Gromann C, Storr M, Böhler T, Seibert E, Girndt M. Randomized controlled pilot study of 2 weeks' treatment with high cutoff membrane for hemodialysis patients with elevated C-reactive protein. Artif Organs. 2012 Oct;36(10):886-93. doi: 10.1111/j.1525-1594.2012.01479.x. Epub 2012 Jul 30.

Responsible Party:	Matthias Girndt, Professor of Internal Medicine, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier:	NCT00974779 History of Changes
Other Study ID Numbers:	KIM2H-2009-02
First Posted:	September 10, 2009
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; inflammation; monocytes; end stage renal disease on regular thrice weekly hemodialysis

Additional relevant MeSH terms:

Inflammation; Kidney Diseases; Kidney Failure, Chronic; Pathologic Processes	Urologic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency