High-cutoff Hemodialyzer to Reduce Chronic Inflammation in Hemodialysis Patients (HCO1100)

Martin-Luther-Universität Halle-Wittenberg

Status and phase: Completed; Phase 3; Phase 2

Conditions: End Stage Renal Disease

Treatments: Device: regular dialysis polyamide; Device: HCO1100 dialyzer

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00974779

KIM2H-2009-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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19 participants in 2 patient groups

HCO dialyzer

Experimental group

Description:

Hemodialysis with the HCO1100 hemodialyzer membrane with high molecular weight cut off.

Treatment:

Device: HCO1100 dialyzer

Placebo

Active Comparator group

Description:

Regular dialysis using a polyamide high-flux hemodialyzer

Treatment:

Device: regular dialysis polyamide