Clinical Study to Assess the Performance of the Dialyzer With Endexo™
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|ClinicalTrials.gov Identifier: NCT03536663|
Recruitment Status : Completed
First Posted : May 25, 2018
Results First Posted : November 12, 2020
Last Update Posted : November 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Kidney Failure, Chronic||Device: Optiflux and Dialyzer with Endexo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||12 HD treatments (4 weeks) with Optiflux dialyzer followed by 38 HD treatments (13 weeks) with Endexo dialyzer|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Clinical Study to Assess the Performance of the Dialyzer With Endexo™ in End-Stage Renal Disease Subjects|
|Actual Study Start Date :||August 29, 2018|
|Actual Primary Completion Date :||April 17, 2019|
|Actual Study Completion Date :||June 17, 2019|
Optiflux (Active Comparator); Hemodialysis treatments on the Optiflux dialyzer (Optiflux Period) for 4 weeks - Visit 1 to 12 Endexo (Experimental); Subjects continue on Dialyzer with Endexo (Endexo Period) for 13 weeks - Visit 13 to visit 50
Device: Optiflux and Dialyzer with Endexo
Hemodialysis (HD) on Optiflux dialyzer from Visit 1 to 12 and followed by HD on the dialyzer with Endexo at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention will be 17 weeks.
- Performance of the Dialyzer With Endexo by Measuring Its in Vivo Ultrafiltration Coefficient [ Time Frame: 15 minutes after the recorded start of hemodialysis with Endexo upon its first use in the study ]Ultrafiltration coefficient (Kuf) is the ratio of ultrafiltration rate in ml/hr to the Transmembrane pressure in mmHg. Both the Ultrafiltration rate and the transmembrane pressure readings are collected from the machine.
- The Number of Any Adverse Events [ Time Frame: Optiflux: from enrollment, weeks 1 to 4 (visits 1 to 12); Endexo: from weeks 5 to 17, and follow-up, a total of 17 weeks intervention. ]All adverse events were captured from subject enrollment to the completion of Optiflux period, and to the end of study or withdraws from the study.
- The Number of Any Device-related Adverse Events [ Time Frame: Optiflux: from enrollment, weeks 1 to 4 (visits 1 to 12); Endexo: from weeks 5 to 17, and follow-up, a total of 17 weeks intervention. ]Any device-related adverse events were captured from subject enrollment to the completion of Optiflux period, and to the end of study or withdraws from the study.
- Removal of Urea [ Time Frame: At visits 1/week 1, 10/week 4, 13/week 5, 22/week 8, 34/week 12, and 46/week 16 ]
- URR = (pre-HD urea - post-HD urea)/pre-HD urea * 100
- Data across visits were averaged for each subject, and then a group mean and sd were calculated.
- Removal of Albumin [ Time Frame: Pre- and Post- HD at Visits 1/week 1, 13/week 5 ]%change = (post-HD - pre-HD)/pre-HD * 100
- Removal of Beta-2-microglobulin [ Time Frame: Pre- and Post- HD at Visits 1/week 1, 13/week 5 ]% reduction = (post-HD - pre-HD)/pre-HD * 100 with post-HD B2M adjusted to pre- and post HD weights
- Dialyzer Hemocompatibility [ Time Frame: Assessed at the first time the dialyzers are used in the study , collected pre hemodialysis and 30 minutes after the recorded start of hemodialysis ]The dialyzer hemo-compatibility is measured by measuring the activation of the complement system (C3a, C5a, SC5b-9)
- Clotting of the Dialyzer [ Time Frame: visual evaluation of the dialyzer arterial cap will be performed at the end of every hemodialysis treatment to determine the Grade:1,2,3 or 4. (1:no clotting to 4: total clotting), throughout a total of 17 weeks intervention. ]Thrombus scoring will be assessed according to a clotting scale (The graded scoring method)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536663
|United States, California|
|Balboa Nephrology Med Group|
|Chula Vista, California, United States, 92154|
|California Institute of Renal Research|
|San Diego, California, United States, 92111|
|United States, Kansas|
|Research Management Inc/ Kansas Nephrology Research Institute, LLC-J/V|
|Wichita, Kansas, United States, 67214|
|Study Director:||Shakil Aslam, MD||Fresenius Medical Care RTG, LLC|
|Principal Investigator:||Dylan Steer, MD||California Institute of Renal Research|
|Principal Investigator:||Lisa Weber, MD||Research Management Inc/ Kansas Nephrology Research Institute, LLC-J/V|
|Principal Investigator:||Jill Meyer, MD||Balboa Nephrology Med Group|