Permeability Enhancement to Reduce Chronic Inflammation (PERCI)
Primary Purpose
End Stage Renal Disease, Inflammation
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
HCO1100
P210H
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease focused on measuring inflammation, dialysis
Eligibility Criteria
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
Sites / Locations
- KfH Bachstzelzenweg 4
- KfH-Bismarkstrasse 95-96
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HCO1100-P14L
P210H
Arm Description
HCO1100 is connected in row with low flux dialyzer P14L
High flux Filter P210H
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Albumin blood level
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)
Full Information
NCT ID
NCT01582893
First Posted
April 11, 2012
Last Updated
April 4, 2017
Sponsor
Baxter Healthcare Corporation
Collaborators
Gambro Dialysatoren GmbH
1. Study Identification
Unique Protocol Identification Number
NCT01582893
Brief Title
Permeability Enhancement to Reduce Chronic Inflammation
Acronym
PERCI
Official Title
Permeability Enhancement to Reduce Chronic Inflammation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxter Healthcare Corporation
Collaborators
Gambro Dialysatoren GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Inflammation
Keywords
inflammation, dialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HCO1100-P14L
Arm Type
Experimental
Arm Description
HCO1100 is connected in row with low flux dialyzer P14L
Arm Title
P210H
Arm Type
Active Comparator
Arm Description
High flux Filter P210H
Intervention Type
Device
Intervention Name(s)
HCO1100
Intervention Description
Dialysis
Intervention Type
Device
Intervention Name(s)
P210H
Intervention Description
Dialysis
Primary Outcome Measure Information:
Title
change of CD162 expression on monocytes
Description
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)
Time Frame
8 weeks (3 weeks treatment phase, 2 weeks wash out phase, 3 weeks treatment phase)
Secondary Outcome Measure Information:
Title
Albumin blood level
Description
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)
Time Frame
8 weeks (3 weeks treatment phase, 2 weeks wash out phase, 3 weeks treatment phase)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Girndt, MD
Organizational Affiliation
Martin-Luther-Universität Halle-Wittenberg
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ralf Schindler, MD
Organizational Affiliation
Charité, Humboldt Universität Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
KfH Bachstzelzenweg 4
City
Halle (Saale)
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06120
Country
Germany
Facility Name
KfH-Bismarkstrasse 95-96
City
Berlin
ZIP/Postal Code
10625
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Permeability Enhancement to Reduce Chronic Inflammation
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