An interventional study of NeoKidney in End Stage Renal Disease and ESRD, sponsored by Nextkidney S.A.. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-21.
Sponsored by Nextkidney S.A. · Not applicable, Interventional, and Treatment
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:
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's planned enrollment of 3 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Nextkidney S.A. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Well-functioning vascular access (native fistula or graft or permanent veinous catheter) defined as:
Exclusion Criteria:
Every patient will receive NeoKidney therapy which will be referenced to SDHD sessions with the usual device as their own baseline. The study is designed in a way that allows an incremental increase of the ratio of NeoKidney versus SDHD sessions with the usual device. In order to minimize the study burden to the patient, most SDHD sessions with the usual device will be done in the patient's home. The NeoKidney therapy sessions, and 2 SDHD sessions with the usual device will be performed in the study center, thus ensuring the necessary patient care and observation as well as sample collection.
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.
Absence 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
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Nextkidney S.A.