PERCI: Permeability Enhancement to Reduce Chronic Inflammation

Sponsor

Baxter Healthcare Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT01582893

Collaborator

Gambro Dialysatoren GmbH (Industry)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Disease Inflammation	Device: HCO1100 Device: P210H	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Permeability Enhancement to Reduce Chronic Inflammation

Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

change of CD162 expression on monocytes [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 Outcome Measures

Albumin blood level [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KfH Bachstzelzenweg 4	Halle (Saale)	Sachsen-Anhalt	Germany	06120
2	KfH-Bismarkstrasse 95-96	Berlin		Germany	10625

Sponsors and Collaborators

Baxter Healthcare Corporation
Gambro Dialysatoren GmbH

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Baxter Healthcare Corporation

ClinicalTrials.gov Identifier:

NCT01582893

Other Study ID Numbers:

1492
CIV-11-10-002741

First Posted:

Apr 23, 2012

Last Update Posted:

Apr 5, 2017

Last Verified:

Apr 1, 2017

Keywords provided by Baxter Healthcare Corporation

inflammation

dialysis

Additional relevant MeSH terms:

Kidney Failure, Chronic

Inflammation

Study Results

No Results Posted as of Apr 5, 2017