High-cutoff Hemodialyzer to Reduce Chronic Inflammation in Hemodialysis Patients
HCO1100
Application of the "High-cutoff (HCO1100)" Hemodialyzer to Reduce Chronic Inflammation in Hemodialysis Patients With Elevated CRP Levels
1 other identifier
interventional
19
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2009
CompletedFirst Posted
Study publicly available on registry
September 10, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJanuary 18, 2012
January 1, 2012
1.7 years
September 9, 2009
January 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Inflammation: CRP plasma level and quantity of circulating CD14/16 positive monocytes
2 weeks
Secondary Outcomes (1)
Serum albumin losses
2 weeks
Study Arms (2)
HCO dialyzer
EXPERIMENTALHemodialysis with the HCO1100 hemodialyzer membrane with high molecular weight cut off.
Placebo
ACTIVE COMPARATORRegular dialysis using a polyamide high-flux hemodialyzer
Interventions
Thrice weekly dialysis using the HCO1100 dialyzer for 4.5h, 2 weeks
Continuation of the regular hemodialysis using polyamide high-flux hemodialysers
Eligibility Criteria
You may qualify if:
- regular hemodialysis for at least 3 months
- treatment thrice weekly
- high-flux hemodialyzer for at least 4 weeks
- age \> 18 years and \< 80 years
- able to understand and consent the study
- written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Internal Medicine II, Martin-Luther-University Medical School
Halle, Saxony-Anhalt, Germany
Related Publications (1)
Fiedler R, Neugebauer F, Ulrich C, Wienke A, Gromann C, Storr M, Bohler T, Seibert E, Girndt M. Randomized controlled pilot study of 2 weeks' treatment with high cutoff membrane for hemodialysis patients with elevated C-reactive protein. Artif Organs. 2012 Oct;36(10):886-93. doi: 10.1111/j.1525-1594.2012.01479.x. Epub 2012 Jul 30.
PMID: 22845695DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Internal Medicine
Study Record Dates
First Submitted
September 9, 2009
First Posted
September 10, 2009
Study Start
November 1, 2009
Primary Completion
August 1, 2011
Study Completion
December 1, 2011
Last Updated
January 18, 2012
Record last verified: 2012-01