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

NCT06024135 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2024-03-21

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

NeoKidney

Progressive exposition to NeoKidney device starting with only one NeoKidney therapy on a mid-week day and 5 SDHD sessions with the usual device in week one, followed by 2 NeoKidney therapies and 4 SDHD sessions with the usual device in week 2, and only progressing to a full week on NeoKidney after a safety review.

Sponsors & Collaborators

  • Monitoring Force Group

    collaborator INDUSTRY

  • Nextkidney S.A.

    lead INDUSTRY

Principal Investigators

  • Maxence Ficheux, Dr · University Hospital, Caen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-11
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06024135 on ClinicalTrials.gov