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

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00974779

Acronym

HCO1100

Enrollment

Registered

2009-09-10

Start date

2009-11-30

Completion date

2011-12-31

Last updated

2012-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease

Keywords

kidney failure chronic, renal dialysis, inflammation, monocytes, end stage renal disease on regular thrice weekly hemodialysis

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.

Interventions

DEVICEHCO1100 dialyzer

Thrice weekly dialysis using the HCO1100 dialyzer for 4.5h, 2 weeks

DEVICEregular dialysis polyamide

Continuation of the regular hemodialysis using polyamide high-flux hemodialysers

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Serum albumin losses	2 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026