High-cutoff Hemodialyzer to Reduce Chronic Inflammation in Hemodialysis Patients (HCO1100)
January 13, 2012 updated by: Matthias Girndt, Martin-Luther-Universität Halle-Wittenberg
Application of the "High-cutoff (HCO1100)" Hemodialyzer to Reduce Chronic Inflammation in Hemodialysis Patients With Elevated CRP Levels
The purpose of this study is to test whether a dialyzer with a higher than usual permeability for proteins can eliminate proinflammatory proteins from the blood of patients on regular maintenance hemodialysis who have chronically elevated levels of inflammation markers such as C-reactive protein (CRP) in their blood.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients with ESRD on chronic hemodialysis patients frequently have elevated markers of inflammation (e.g.
serum CRP values).
Hemodialysis may clear the blood from low molecular weight toxins and retention products such as creatinine, potassium, or urea.
The dialyzer clearance of middle to high molecular weight substances such as cytokines and cytokine receptors is low.
Nearly 50% of chronic dialysis patients have persistent subclinical inflammation which is strongly associated with cardiovascular disease and mortality.
The study tests the hypothesis that removal of proteins in the weight range of 10.000-30.000
D via a more permeable dialyzer membrane reduces chronic inflammation in these patients.
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sachsen-Anhalt
-
Halle (Saale), Sachsen-Anhalt, Germany
- Department of Internal Medicine II, Martin-Luther-University Medical School
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- regular hemodialysis for at least 3 months
- treatment thrice weekly
- high-flux hemodialyzer for at least 4 weeks
- age > 18 years and < 80 years
- at least one CRP value > 5mg/L within 8 weeks before inclusion
- able to understand and consent the study
- written informed consent
Exclusion Criteria:
- no consent
- clinically apparent acute infection
- CRP > 50 mg/L
- serum albumin < 3,5 mg/L
- central venous line as dialysis access
- immunosuppressive medication
- pregnancy or lactation
- inclusion into any other interventional trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: HCO dialyzer
Hemodialysis with the HCO1100 hemodialyzer membrane with high molecular weight cut off.
|
Thrice weekly dialysis using the HCO1100 dialyzer for 4.5h, 2 weeks
Other Names:
|
|
Active Comparator: Placebo
Regular dialysis using a polyamide high-flux hemodialyzer
|
Continuation of the regular hemodialysis using polyamide high-flux hemodialysers
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Inflammation: CRP plasma level and quantity of circulating CD14/16 positive monocytes
Time Frame: 2 weeks
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Serum albumin losses
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
September 9, 2009
First Submitted That Met QC Criteria
September 9, 2009
First Posted (Estimate)
September 10, 2009
Study Record Updates
Last Update Posted (Estimate)
January 18, 2012
Last Update Submitted That Met QC Criteria
January 13, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KIM2H-2009-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.