Permeability Enhancement to Reduce Chronic Inflammation

Not Applicable

Completed

• Conditions: Inflammation; End Stage Renal Disease
• Interventions: Device: P210H; Device: HCO1100

• Registration Number: NCT01582893
• Lead Sponsor: Vantive Health LLC

Brief Summary

Chronic dialysis patients with end stage renal disease have an increased mortality rate as compared to the age matched healthy population. It is known that chronic inflammation contributes to the high incidence of cardiovascular events in chronic dialysis patients. Dialyzers made by membranes with increased pore size (high cut-off Dialyzer HCO1100) may be beneficial in the elimination of inflammatory mediators and may improve the inflammatory status. Hypothesis: In this study it will be investigated whether the treatment with HCO1100 will improve the inflammatory status of chronic dialysis patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-11
• Study First Submitted QC: 2012-04-19
• Study First Posted: 2012-04-23
• Primary Completion: 2012-10
• Study Completion: 2013-07
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Dialysis treatment for ≥ 3 months
• Dialysis 3x weekly
• Vascular access by fistula or CVC providing QB of ≥ 250 ml/min
• Dialysis with high-flux dialyzer for a minimum of 2 weeks before begin of study
• CRP > 5mg/L at least once within 12 weeks before inclusion
• Age > 18 and < 99 Years
• Ability to give written informed consent

Exclusion Criteria

• Missing informed consent form
• Clinically manifested infection or current CRP-value > 50mg/L
• Serum albumin < 35g/L
• Intake of immune suppressive medication
• Pregnancy or lactation
• Participation in a different study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
P210H	P210H	High flux Filter P210H
HCO1100-P14L	HCO1100	HCO1100 is connected in row with low flux dialyzer P14L

Primary Outcome Measures

Name	Time	Method
change of CD162 expression on monocytes	8 weeks (3 weeks treatment phase, 2 weeks wash out phase, 3 weeks treatment phase)	change of CD162 expression on monocytes, timepoints in each treatment phase: 1.)1st.day (prae dialysis) 2.)1st.day (post dialysis) 3.)2nd.day (prae dialysis) 4.)8th.day (prae dialysis) 5.)15th.day (prae dialysis) 6.)22nd.day (prae dialysis)

Secondary Outcome Measures

Name	Time	Method
Albumin blood level	8 weeks (3 weeks treatment phase, 2 weeks wash out phase, 3 weeks treatment phase)	change of albumin blood level, timepoints in each treatment phase: 1.)1st.day (prae dialysis) 2.)1st.day (post dialysis) 3.)2nd.day (prae dialysis) 4.)8th.day (prae dialysis) 5.)15th.day (prae dialysis) 6.)22nd.day (prae dialysis)

Trial Locations

Locations (2)

KfH-Bismarkstrasse 95-96; 🇩🇪 Berlin, Germany

KfH Bachstzelzenweg 4; 🇩🇪 Halle (Saale), Sachsen-Anhalt, Germany