High-cutoff Hemodialyzer to Reduce Chronic Inflammation in Hemodialysis Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Application of the High-cutoff (HCO1100) Hemodialyzer to Reduce Chronic Inflammation in Hemodialysis Patients With Elevated CRP Levels

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Device: HCO1100 dialyzer
* Device: regular dialysis polyamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HCO dialyzer<br>Hemodialysis with the HCO1100 hemodialyzer membrane with high molecular weight cut off. | Device: HCO1100 dialyzer<br>* Thrice weekly dialysis using the HCO1100 dialyzer for 4.5h, 2 weeks<br>* Other names: Gambro HCO1100;|
| Active Comparator: Placebo<br>Regular dialysis using a polyamide high-flux hemodialyzer | Device: regular dialysis polyamide<br>* Continuation of the regular hemodialysis using polyamide high-flux hemodialysers<br>* Other names: Gambro Polyflux 11;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation: CRP plasma level and quantity of circulating CD14/16 positive monocytes |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum albumin losses |  | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kidney failure chronic, renal dialysis, inflammation, monocytes, end stage renal disease on regular thrice weekly hemodialysis