Permeability Enhancement to Reduce Chronic Inflammation

Inflammation Clinical Trial

— PERCI  

Official title:

Permeability Enhancement to Reduce Chronic Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01582893
• Other study ID #: 1492
• Secondary ID: CIV-11-10-002741
• Status: Completed
• Phase: N/A
• First received: April 11, 2012
• Last updated: April 4, 2017
• Start date: April 2012
• Est. completion date: July 2013

Study information

• Verified date: April 2017
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Inflammation
• Kidney Failure, Chronic

Intervention

Device:
• HCO1100
Dialysis
• P210H
Dialysis

Locations

Country	Name	City	State
Germany	KfH-Bismarkstrasse 95-96	Berlin
Germany	KfH Bachstzelzenweg 4	Halle (Saale)	Sachsen-Anhalt

Sponsors (2)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation	Gambro Dialysatoren GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	8 weeks (3 weeks treatment phase, 2 weeks wash out phase, 3 weeks treatment phase)
Secondary	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)	8 weeks (3 weeks treatment phase, 2 weeks wash out phase, 3 weeks treatment phase)