NCT00974779

High-cutoff Hemodialyzer to Reduce Chronic Inflammation in Hemodialysis Patients

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Martin-Luther-Universität Halle-Wittenberg · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
DEVICE	HCO1100 dialyzer	Thrice weekly dialysis using the HCO1100 dialyzer for 4.5h, 2 weeks
DEVICE	regular dialysis polyamide	Continuation of the regular hemodialysis using polyamide high-flux hemodialysers

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-08-01
• Completion: 2011-12-01
• First posted: 2009-09-10
• Last updated: 2012-01-18

Locations

1 site across 1 country: Germany