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.
Age range
18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Absence of serious adverse events (SAE) and of serious adverse device effects (SADE).
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: Through the end of last patient follow-up visit, an average of 2 months
Absence of critical change in pH pre- vs post-treatment
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: Through the end of last patient follow-up visit, an average of 2 months