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Completed

NCT Number: NCT01582893

Permeability Enhancement to Reduce Chronic Inflammation

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.

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KfH Bachstzelzenweg 4, Halle, Saxony-Anhalt, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HCO1100

Device

Dialysis

P210H

Device

Dialysis

Primary outcomes

  1. change of CD162 expression on monocytes

    Time frame: 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 outcomes

  1. Albumin blood level

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Vantive Health LLC

Industry

Collaborators

  • Baxter Healthcare Corporation
  • Gambro Dialysatoren GmbH

Registry information

Acronym: PERCI

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Apr 23, 2012
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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