CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 23 enrolled
Drug / intervention
Optiflux and Dialyzer with Endexodevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03536663
NCT03536663N/ACompleted
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An Open-Label Clinical Study to Assess the Performance of the Dialyzer With Endexo™ in End-Stage Renal Disease Subjects

Fresenius Medical Care North America·interventional·Posted May 25, 2018·Updated Nov 27, 2020

In Brief

A clinical study evaluating Optiflux and Dialyzer with Endexo for Kidney Failure, Chronic. Completed, enrolled 23 participants across 3 sites.

Detailed Summary

Endexo™ is an additive that is blended into the fiber solution during manufacturing of the hemodialyzer hollow fibers. The intended purpose of the additive is to increase blood compatibility in the finished dialyzer, which is referred to as the "dialyzer with Endexo."

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Failure, Chronic
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMay 25, 2018
Enrollment StartAug 29, 2018
Primary CompletionApr 17, 2019
Study CompletionJun 17, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 8.1 years ago

Interventions

Optiflux and Dialyzer with Endexodevice

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.