High-cutoff Hemodialyzer to Reduce Chronic Inflammation in Hemodialysis Patients (HCO1100)
This study has been completed.
Sponsor:
Martin-Luther-Universität Halle-Wittenberg
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
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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:
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 (Adult, Senior) |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00974779
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
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 Renal Insufficiency, Chronic |
Pathologic Processes Urologic Diseases Renal Insufficiency |
ClinicalTrials.gov processed this record on September 26, 2016