High-cutoff Hemodialyzer to Reduce Chronic Inflammation in Hemodialysis Patients (HCO1100)
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ClinicalTrials.gov Identifier: NCT00974779 |
Recruitment Status
:
Completed
First Posted
: September 10, 2009
Last Update Posted
: January 18, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
End Stage Renal Disease | Device: HCO1100 dialyzer Device: regular dialysis polyamide | Phase 2 Phase 3 |
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 |

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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00974779
Germany | |
Department of Internal Medicine II, Martin-Luther-University Medical School | |
Halle (Saale), Sachsen-Anhalt, Germany |
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 |
First Posted: | September 10, 2009 Key Record Dates |
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 |