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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
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.
CHU de Caen
Caen, Normandy, France
RECRUITINGAbsence of serious adverse events (SAE) and of serious adverse device effects (SADE).
To assess the safety of the NeoKidney in a small number (n=3) of patients and HD sessions (9 sessions per patient).
Time frame: Through the end of last patient follow-up visit, an average of 2 months
Absence of critical change in patient's blood pressure (mm Hg) during treatment
To assess the safety of the NeoKidney on patient's clinical condition and vital parameters, in a small number (n=3) of patients and HD sessions (9 sessions per patient).
Time frame: Through the end of last patient follow-up visit, an average of 2 months
Absence of critical change in patient's heart rate (bpm) during treatment
To assess the safety of the NeoKidney on patient's clinical condition and vital parameters, in a small number (n=3) of patients and HD sessions (9 sessions per patient).
Time frame: Through the end of last patient follow-up visit, an average of 2 months
Absence of critical change in patient's body temperature (°C) during treatment
To assess the safety of the NeoKidney on patient's clinical condition and vital parameters, in a small number (n=3) of patients and HD sessions (9 sessions per patient).
Time frame: Through the end of last patient follow-up visit, an average of 2 months
Absence of critical change in patient's pulse oximetry (% SpO2) during treatment
To assess the safety of the NeoKidney on patient's clinical condition and vital parameters, in a small number (n=3) of patients and HD sessions (9 sessions per patient).
Time frame: Through the end of last patient follow-up visit, an average of 2 months
Absence of critical change in bicarbonates (mmol/L) pre- vs post-treatment
To assess the safety of the NeoKidney on hematology and clinical chemistry pre- vs post-treatment in a small number (n=3) of patients and HD sessions (9 sessions per patient).
Time frame: Through the end of last patient follow-up visit, an average of 2 months
Absence of critical change in pH pre- vs post-treatment
To assess the safety of the NeoKidney on hematology and clinical chemistry pre- vs post-treatment in a small number (n=3) of patients and HD sessions (9 sessions per patient).
Time frame: Through the end of last patient follow-up visit, an average of 2 months
Absence of critical change in LDH (UI/L) pre- vs post-treatment
To assess the safety of the NeoKidney on hematology and clinical chemistry pre- vs post-treatment in a small number (n=3) of patients and HD sessions (9 sessions per patient).
Time frame: Through the end of last patient follow-up visit, an average of 2 months
Absence of critical change in Haptoglobin (g/L) pre- vs post-treatment
To assess the safety of the NeoKidney on hematology and clinical chemistry pre- vs post-treatment in a small number (n=3) of patients and HD sessions (9 sessions per patient).
Time frame: Through the end of last patient follow-up visit, an average of 2 months
Absence of critical change in Sodium (mmol/L) pre- vs post-treatment
To assess the safety of the NeoKidney on hematology and clinical chemistry pre- vs post-treatment in a small number (n=3) of patients and HD sessions (9 sessions per patient).
Time frame: Through the end of last patient follow-up visit, an average of 2 months
Absence of critical change in Potassium (mmol/L) pre- vs post-treatment
To assess the safety of the NeoKidney on hematology and clinical chemistry pre- vs post-treatment in a small number (n=3) of patients and HD sessions (9 sessions per patient).
Time frame: Through the end of last patient follow-up visit, an average of 2 months
Absence of critical change in Phosphate (mmol/L) pre- vs post-treatment
To assess the safety of the NeoKidney on hematology and clinical chemistry pre- vs post-treatment in a small number (n=3) of patients and HD sessions (9 sessions per patient).
Time frame: Through the end of last patient follow-up visit, an average of 2 months
Absence of critical change in Calcium (mmol/L) pre- vs post-treatment
To assess the safety of the NeoKidney on hematology and clinical chemistry pre- vs post-treatment in a small number (n=3) of patients and HD sessions (9 sessions per patient).
Time frame: Through the end of last patient follow-up visit, an average of 2 months
Absence of critical change in Chlorine (mmol/L) pre- vs post-treatment
To assess the safety of the NeoKidney on hematology and clinical chemistry pre- vs post-treatment in a small number (n=3) of patients and HD sessions (9 sessions per patient).
Time frame: Through the end of last patient follow-up visit, an average of 2 months
Absence of critical change in Magnesium (mmol/L) pre- vs post-treatment
To assess the safety of the NeoKidney on hematology and clinical chemistry pre- vs post-treatment in a small number (n=3) of patients and HD sessions (9 sessions per patient).
Time frame: Through the end of last patient follow-up visit, an average of 2 months
Absence of critical change in Magnesium (µmol/L) pre- vs post-treatment
To assess the safety of the NeoKidney on hematology and clinical chemistry pre- vs post-treatment in a small number (n=3) of patients and HD sessions (9 sessions per patient).
Time frame: Through the end of last patient follow-up visit, an average of 2 months
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