Status:
COMPLETED
High-cutoff Hemodialyzer to Reduce Chronic Inflammation in Hemodialysis Patients
Lead Sponsor:
Martin-Luther-Universität Halle-Wittenberg
Collaborating Sponsors:
Gambro Dialysatoren GmbH
KfH Kuratorium für Dialyse und Nierentransplantation e.V., Neu Isenburg, Germany
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
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 hemo...
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 rete...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00974779
Start Date
November 1 2009
End Date
December 1 2011
Last Update
January 18 2012
Active Locations (1)
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1
Department of Internal Medicine II, Martin-Luther-University Medical School
Halle, Saxony-Anhalt, Germany