Permeability Enhancement to Reduce Chronic Inflammation (PERCI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gambro Dialysatoren GmbH
ClinicalTrials.gov Identifier:
NCT01582893
First received: April 11, 2012
Last updated: July 1, 2013
Last verified: July 2013
  Purpose

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 Intervention
End Stage Renal Disease
Inflammation
Device: HCO1100
Device: P210H

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Permeability Enhancement to Reduce Chronic Inflammation

Resource links provided by NLM:


Further study details as provided by Gambro Dialysatoren GmbH:

Primary Outcome Measures:
  • change of CD162 expression on monocytes [ Time Frame: 8 weeks (3 weeks treatment phase, 2 weeks wash out phase, 3 weeks treatment phase) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 weeks (3 weeks treatment phase, 2 weeks wash out phase, 3 weeks treatment phase) ] [ Designated as safety issue: Yes ]
    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)


Enrollment: 50
Study Start Date: April 2012
Study Completion Date: July 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01582893

Locations
Germany
KfH Bachstzelzenweg 4
Halle (Saale), Sachsen-Anhalt, Germany, 06120
KfH-Bismarkstrasse 95-96
Berlin, Germany, 10625
Sponsors and Collaborators
Gambro Dialysatoren GmbH
Investigators
Study Director: Matthias Girndt, MD Martin-Luther-Universität Halle-Wittenberg
Principal Investigator: Ralf Schindler, MD Charité, Humboldt Universität Berlin
  More Information

No publications provided

Responsible Party: Gambro Dialysatoren GmbH
ClinicalTrials.gov Identifier: NCT01582893     History of Changes
Other Study ID Numbers: 1492, CIV-11-10-002741
Study First Received: April 11, 2012
Last Updated: July 1, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Gambro Dialysatoren GmbH:
inflammation
dialysis

Additional relevant MeSH terms:
Inflammation
Kidney Diseases
Kidney Failure, Chronic
Pathologic Processes
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on August 18, 2014