Clinical trial NCT00974779: High-cutoff Hemodialyzer to Reduce Chronic Inflammation in Hemodialysis Patients
Official title: Application of the "High-cutoff (HCO1100)" Hemodialyzer to Reduce Chronic Inflammation in Hemodialysis Patients With Elevated CRP Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: End Stage Renal Disease
Keywords: kidney failure chronic
renal dialysis
inflammation
monocytes
end stage renal disease on regular thrice weekly hemodialysis
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
Collaborators: name: Gambro Dialysatoren GmbH
name: KfH Kuratorium für Dialyse und Nierentransplantation e.V., Neu Isenburg, Germany
First posted: 2009-09-10
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Inflammation: CRP plasma level and quantity of circulating CD14/16 positive monocytes
timeFrame: 2 weeks
Secondary outcomes:
measure: Serum albumin losses
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Halle (Saale)
country: Germany
facility: Department of Internal Medicine II, Martin-Luther-University Medical School
state: Sachsen-Anhalt
Study officials:
References:
citation: Fiedler R, Neugebauer F, Ulrich C, Wienke A, Gromann C, Storr M, Bohler T, Seibert E, Girndt M. Randomized controlled pilot study of 2 weeks' treatment with high cutoff membrane for hemodialysis patients with elevated C-reactive protein. Artif Organs. 2012 Oct;36(10):886-93. doi: 10.1111/j.1525-1594.2012.01479.x. Epub 2012 Jul 30.