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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

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring inflammation, dialysis

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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

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

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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