Permeability Enhancement to Reduce Chronic Inflammation (PERCI)

April 4, 2017 updated by: Baxter Healthcare Corporation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10625
        • KfH-Bismarkstrasse 95-96
    • Sachsen-Anhalt
      • Halle (Saale), Sachsen-Anhalt, Germany, 06120
        • KfH Bachstzelzenweg 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HCO1100-P14L
HCO1100 is connected in row with low flux dialyzer P14L
Device: HCO1100
Dialysis
Active Comparator: P210H
High flux Filter P210H
Device: P210H
Dialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
8 weeks (3 weeks treatment phase, 2 weeks wash out phase, 3 weeks treatment phase)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
8 weeks (3 weeks treatment phase, 2 weeks wash out phase, 3 weeks treatment phase)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baxter Healthcare Corporation

Collaborators

Gambro Dialysatoren GmbH

Investigators

  • Study Director: Matthias Girndt, MD, Martin-Luther-Universität Halle-Wittenberg
  • Principal Investigator: Ralf Schindler, MD, Charité, Humboldt Universität Berlin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

April 11, 2012

First Submitted That Met QC Criteria

April 19, 2012

First Posted (Estimate)

April 23, 2012

Study Record Updates

Last Update Posted (Actual)

April 5, 2017

Last Update Submitted That Met QC Criteria

April 4, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1492 (Other Identifier: CSL Behring)
  • CIV-11-10-002741 (Other Identifier: Eudamed)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Inflammation

Clinical Trials on HCO1100

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe