Permeability Enhancement to Reduce Chronic Inflammation

NCT01582893 | Completed

• 2 other identifiers: 1492CIV-11-10-002741
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

End Stage Renal Disease; Inflammation

Keywords

inflammation; dialysis

Outcome Measures

Primary Outcomes (1)

• change of CD162 expression on monocytes

  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)

  8 weeks (3 weeks treatment phase, 2 weeks wash out phase, 3 weeks treatment phase)

Secondary Outcomes (1)

• Albumin blood level

  8 weeks (3 weeks treatment phase, 2 weeks wash out phase, 3 weeks treatment phase)

Study Arms (2)

HCO1100-P14L

EXPERIMENTAL

HCO1100 is connected in row with low flux dialyzer P14L

Device: HCO1100

P210H

ACTIVE COMPARATOR

High flux Filter P210H

Device: P210H

Interventions

HCO1100 DEVICE

Dialysis

HCO1100-P14L

P210H DEVICE

Dialysis

P210H

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Age \> 18 and \< 99 Years
• Ability to give written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Vantive Health LLC: lead
• Gambro Dialysatoren GmbH: collaborator
• Baxter Healthcare Corporation: collaborator

Study Sites (2)

KfH Bachstzelzenweg 4

Halle, Saxony-Anhalt, 06120, Germany

Location

KfH-Bismarkstrasse 95-96

Berlin, 10625, Germany

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Inflammation

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthias Girndt, MD

  Martin-Luther-Universität Halle-Wittenberg

  STUDY DIRECTOR

• Ralf Schindler, MD

  Charité, Humboldt Universität Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2012
• First Posted: April 23, 2012
• Study Start: April 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: July 1, 2013
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

DE (2)