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Completed

NCT Number: NCT02433210

A Clinical Study Comparing Basic Performance and Hemocompatibility of 3 Different Dialyzers in Hemodialysis Patients

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.

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Key information

Conditions

End Stage Renal Disease (ESRD) Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dialysis Clinic Incorporated

Columbia, Missouri, 65201, United States

About this study

Current patients receiving dialysis treatment for end stage renal disease and who meet the inclusion/exclusion criteria will be entered into the study. These patients will continue on their standard dialysis regimen as stated in the clinics Standard Operating Procedures. Each patient will be studied for three weeks with each week starting with a dialyzer of a different manufacture but of comparable characteristics. Solute clearances and removal will be determined at each of the three dialysis sessions during the week. During session 2 of each week additional specimens will be taken to analyze for hemocompatibility. At the end of the study all clearances and the hemocompatibility markers for each dialyzer will be compared to one another as well as to the manufactures stated characteristics. Blood for the clearance and removal calculations will be taken at time 0, 60 minutes and 240 minutes. Blood for the hemocompatibility determinations will be taken at time 0, 15, 30, 60 and 240 minutes. Flow rates, anticoagulant therapy, erythropoietin therapy, venous and arterial pressures will also be recorded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

ELISIO-15H

Device

Each patient to undergo 3 successive hemodialysis/week with this dialyzer.

Other names: dialyzer

Revaclear

Device

Each patient to undergo 3 successive hemodialysis/week with this dialyzer.

Other names: Dialyzer

Optiflux

Device

Each patient to undergo 3 successive hemodialysis/week with this dialyzer.

Other names: Dialyzer

Primary outcomes

  1. Clearance and Solute Removal Characteristics of Dialyzers

    Time frame: During each of the three weekly dialysis sessions measurements of urea were made at the 60 minute time point for each patient in the study. At the end of the study all measurements were summed for each of the three dialyzers.

    Clearances of small, middle and large molecular weight solutes will be measured at 60 minute time point utilizing urea, creatinine, beta 2 microglobulin, phosphate and myoglobin. Dialyzer clearance is calculated as follows: 60 minute clearance:((([S]60'Art - [S]60'Ven) / [S]60'Art) * Qb) where [S] = solute concentration; Qb = blood flow rate. S

  2. Hemocompatibility as Shown by C5a for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers of Dialyzers

    Time frame: Once a week during the second of the three weekly sessions specimens will be taken at time points 0, 15, 30, 60 and 240 minutes. Measurements, all patients, were summed for each dialyzer type by time period.

    The molecules monitored will be C5a, thrombin/anti-thrombin complex and a complete blood count with platelets.

  3. Hemocompatibility as Shown by Thrombin/Antithrombin Complex for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers.

    Time frame: Once a week during the second of the three weekly sessions specimens will be taken at the 60 and 240 minutes timepoints. Measurements for all patients were summed for each dialyzer type by time period for analysis..

    Measure of the % change from Baseline for the hemocompatibility marker Thrombin/Antithrombin complex for the Optiflux, Revaclear, and ELISIO dialyzers.

  4. Hemocompatibility as Shown by Hematocrit for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers

    Time frame: Once a week during the second of three weekly sessions samples will be taken at the 0, 15, 30, 60, and 240 minute timepoints. Measurements for all patients were summed for each dialyzer type by time period for analysis.

    Measure of the % change from Baseline for the hemocompatibility marker Hematocrit for the Optiflux, Revaclear, and ELISIO dialyzers.

  5. Hemocompatibility as Shown by Hemoglobin for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers

    Time frame: Once a week during the second of the three weekly sessions samples will be taken at the 0, 15, 30, 60 and 240 minutes time points. Measurements for all patients were summed for each dialyzer type and time point for analysis.

    Measure of the % change from Baseline for the hemocompatibility marker Hemoglobin for the Optiflux, Revaclear, and ELISIO dialyzers.

  6. Hemocompatibility as Shown by White Cell Count for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers

    Time frame: Once a week during the second of the three weekly sessions samples will be taken at the 0, 15, 30, 60 and 240 minutes time periods. All measurements for all patients were summed for each dialyzer type and time point.

    Measure of the % change from Baseline for the hemocompatibility marker White Cell Count for the Optiflux, Revaclear, and ELISIO dialyzers.

  7. Hemocompatibility as Shown by Platelets for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers

    Time frame: Once a week during the second of the three weekly sessions samples will be taken at the 0, 15, 30, 60 and 240 minutes time periods. All measurements for all patients were summed for each dialyzer type and time point.

    Measure of the % change from Baseline for the hemocompatibility marker Platelets for the Optiflux, Revaclear, and ELISIO dialyzers.

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Collaborators

  • Dialysis Clinic, Inc.
  • Nipro Medical Corporation

Registry information

Official study title

A Clinical Study Comparing the Basic Performance and Blood Compatibility Characteristics of Nipro ELISIO-H, Gambro Polyflux Revaclear and Fresenius Optiflux Dialyzers

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
May 4, 2015
Registry last updated
Aug 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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