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Safety and Efficacy Assessments of NeoKidney® in ESRD Patients Treated With Short Daily Hemodialysis — FIH Caen  

End Stage Renal Disease Clinical Trial

Official title:
Safety and Efficacy Assessments of NeoKidney®, a New Sorbent-based Hemodialysis Device, in ESRD Patients Treated With Short Daily Hemodialysis: a First in Human Use.

Clinical Trial Summary

The goal of this clinical investigation is to asses the safety and efficacy a new sorbent-based hemodialysis device, NeoKidney® in ESRD patients treated with short daily hemodialysis. Participants (stable SDHD patients) will undergo hemodialysis treatement on the NeoKidney® device at the hospital on a progressive exposition to the device: - The first week, patient will be treated once with NeoKidney® on Wednesday - The 2nd week the patient will be treated two consecutive days with NeoKidney® (in the middle of the week) - On the 3rd week, after approval by the DSMB, the patients will be treated 6 consecutive days, in hospital, with the NeoKidney All the other sessions will be performed with the patient's usual SDHD device at home except for two sessions prior to NeoKidney® sessions at Week 1 and 2.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06024135
Study type Interventional
Source Nextkidney S.A.
Contact Baptiste Juillard
Phone +33 1 89 81 71 24
Email baptiste.juillard@monitoring-force.fr
Status Recruiting
Phase N/A
Start date March 11, 2024
Completion date June 2024
View Details
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