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

This study has been completed.
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT00974779
First received: September 9, 2009
Last updated: January 13, 2012
Last verified: January 2012
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Inflammation: CRP plasma level and quantity of circulating CD14/16 positive monocytes [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum albumin losses [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00974779

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

No publications provided by Martin-Luther-Universität Halle-Wittenberg

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

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
Study First Received: September 9, 2009
Last Updated: January 13, 2012
Health Authority: Germany: German Institute of Medical Documentation and Information

Keywords provided by 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

ClinicalTrials.gov processed this record on May 19, 2013