A Clinical Study Comparing Basic Performance and Hemocompatibility of 3 Different Dialyzers in Hemodialysis Patients
Completed · Not applicable
Conditions studied: End Stage Renal Disease (ESRD)
In brief
The aim of the study is to confirm the safety and clinical effectiveness of Nipro ELISIO-15H and to compare its performance characteristics and hemocompatibility with those of the commercially available dialyzers in U.S.A., Gambro Polyflux Revaclear and Fresenius F160NRe. 10 stable patients will be dialyzed 3 times/week with each dialyzer over 3 weeks. Blood samples for several parameters will be collected during hemodialysis to assess the performance and hemocompatibility of the dialyzers under study. Data thus collected will be analyzed for comparison by standard statistical analysis.
Key facts
- Study ID
- NCT02433210
- Run by
- University of Missouri-Columbia
- People needed
- 11
- Starts
- 2015-06-01
- Expected to finish
- 2018-08-31
- Last updated by the study team
- 2022-08-05
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ESRD patients 18 years or older
- Stable on hemodialysis for more than 3 months
- Stable hemoglobin between 11-12 g/dl
- Stable arteriovenous (AV) fistula vascular access
- Stable anticoagulation and ESA regimen
- No active infection
- Able to sign informed consent and able to participate in the study
- Medically stable
You may not qualify if…
- Participation in another study which may interfere with the planned study
- Active infection
- Medical conditions which may interfere with the study (cardiac, liver disease, Hepatitis)
- Allergy to dialyzer membrane materials e.g. polysulfone
- Patients which cannot tolerate Heparin
- Female who are pregnant or planning to be pregnant
- Problem with or allergy to anticoagulation
Where it is running
- Dialysis Clinic Incorporated — Columbia, Missouri, United States
Full record on ClinicalTrials.gov
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