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

Primary Purpose

End Stage Renal Disease

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
HCO1100 dialyzer
regular dialysis polyamide
Sponsored by
Martin-Luther-Universität Halle-Wittenberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring kidney failure chronic, renal dialysis, inflammation, monocytes, end stage renal disease on regular thrice weekly hemodialysis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HCO dialyzer

Placebo

Arm Description

Hemodialysis with the HCO1100 hemodialyzer membrane with high molecular weight cut off.

Regular dialysis using a polyamide high-flux hemodialyzer

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Serum albumin losses

Full Information

First Posted
September 9, 2009
Last Updated
January 13, 2012
Sponsor
Martin-Luther-Universität Halle-Wittenberg
Collaborators
Gambro Dialysatoren GmbH, KfH Kuratorium für Dialyse und Nierentransplantation e.V., Neu Isenburg, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT00974779
Brief Title
High-cutoff Hemodialyzer to Reduce Chronic Inflammation in Hemodialysis Patients
Acronym
HCO1100
Official Title
Application of the "High-cutoff (HCO1100)" Hemodialyzer to Reduce Chronic Inflammation in Hemodialysis Patients With Elevated CRP Levels
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Martin-Luther-Universität Halle-Wittenberg
Collaborators
Gambro Dialysatoren GmbH, KfH Kuratorium für Dialyse und Nierentransplantation e.V., Neu Isenburg, Germany

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
kidney failure chronic, renal dialysis, inflammation, monocytes, end stage renal disease on regular thrice weekly hemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HCO dialyzer
Arm Type
Experimental
Arm Description
Hemodialysis with the HCO1100 hemodialyzer membrane with high molecular weight cut off.
Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
Regular dialysis using a polyamide high-flux hemodialyzer
Intervention Type
Device
Intervention Name(s)
HCO1100 dialyzer
Other Intervention Name(s)
Gambro HCO1100
Intervention Description
Thrice weekly dialysis using the HCO1100 dialyzer for 4.5h, 2 weeks
Intervention Type
Device
Intervention Name(s)
regular dialysis polyamide
Other Intervention Name(s)
Gambro Polyflux 11
Intervention Description
Continuation of the regular hemodialysis using polyamide high-flux hemodialysers
Primary Outcome Measure Information:
Title
Inflammation: CRP plasma level and quantity of circulating CD14/16 positive monocytes
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Serum albumin losses
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Department of Internal Medicine II, Martin-Luther-University Medical School
City
Halle (Saale)
State/Province
Sachsen-Anhalt
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
22845695
Citation
Fiedler R, Neugebauer F, Ulrich C, Wienke A, Gromann C, Storr M, Bohler 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.
Results Reference
derived

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High-cutoff Hemodialyzer to Reduce Chronic Inflammation in Hemodialysis Patients

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