High-cutoff Hemodialyzer to Reduce Chronic Inflammation in Hemodialysis Patients

Phase 2

Completed

• Conditions: End Stage Renal Disease
• Interventions: Device: regular dialysis polyamide; Device: HCO1100 dialyzer

• Registration Number: NCT00974779
• Lead Sponsor: Martin-Luther-Universität Halle-Wittenberg

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.

Study Timeline

• Study First Submitted: 2009-09-09
• Study First Submitted QC: 2009-09-09
• Study First Posted: 2009-09-10
• Study Start: 2009-11
• Primary Completion: 2011-08
• Study Completion: 2011-12
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-13
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	regular dialysis polyamide	Regular dialysis using a polyamide high-flux hemodialyzer
HCO dialyzer	HCO1100 dialyzer	Hemodialysis with the HCO1100 hemodialyzer membrane with high molecular weight cut off.

Primary Outcome Measures

Name	Time	Method
Inflammation: CRP plasma level and quantity of circulating CD14/16 positive monocytes	2 weeks

Secondary Outcome Measures

Name	Time	Method
Serum albumin losses	2 weeks

Trial Locations

Locations (1)

Department of Internal Medicine II, Martin-Luther-University Medical School; 🇩🇪 Halle (Saale), Sachsen-Anhalt, Germany