A Phase 2/3 interventional study of HCO1100 dialyzer and regular dialysis polyamide in End Stage Renal Disease, sponsored by Martin-Luther-Universität Halle-Wittenberg. Completed at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-01-18.
Sponsored by Martin-Luther-Universität Halle-Wittenberg · Phase 2/3, Interventional, and Treatment
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.
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 19 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Martin-Luther-Universität Halle-Wittenberg is the lead sponsor of 62 studies on the registry; 5 are open to participants now.
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Inclusion Criteria:
Exclusion Criteria:
Hemodialysis with the HCO1100 hemodialyzer membrane with high molecular weight cut off.
Device: HCO1100 dialyzer
Regular dialysis using a polyamide high-flux hemodialyzer
Device: regular dialysis polyamide
Thrice weekly dialysis using the HCO1100 dialyzer for 4.5h, 2 weeks
Also known as: Gambro HCO1100
Continuation of the regular hemodialysis using polyamide high-flux hemodialysers
Also known as: Gambro Polyflux 11
Inflammation: CRP plasma level and quantity of circulating CD14/16 positive monocytes
Time frame: 2 weeks
Serum albumin losses
Time frame: 2 weeks
This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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Martin-Luther-Universität Halle-Wittenberg