End Stage Renal DiseaseFIH CaenNCT06024135
Safety and Efficacy Assessments of NeoKidney® in ESRD Patients Treated With Short Daily Hemodialysis
A study testing NeoKidney in people with End Stage Renal Disease and ESRD, run by Nextkidney S.A. at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, ESRD
- What is being tested?
- NeoKidney
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2024to 23 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 years or over;
- Treated with short-daily hemodialysis (1.5-3 h sessions) 5-6 times a week for at least 3 months;
- Estimated Urea removal concentration between [220 to 550] mmol. (Estimation based on the formula: ([Dry Weigh in kg]*] x 0,6)*([) x ([Last pre-dialysis urea concentration in mmol/L]*] x 0,5).
- Well-functioning vascular access (native fistula or graft or permanent veinous catheter) defined as:
- Capable of providing a blood flow rate of ≥200 mL/min, AND
- Absence of vascular access revision for at least 3 months
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- For females of reproducible age, negative urinary pregnancy test and use of appropriate birth control method(s);
- Ability to understand the informed consent and give informed consent;
- Willingness and ability to comply with study procedures and to attend all study follow up visits
Who cannot join
- Post-dialysis body weight below 41.0 kg
- Hb <10.0 g/L, or pre-dialysis [Na] < 132 and > 145 mmol/L, pre-dialysis [K] < 3.5 and > 6 mmol/L and pre-dialysis [HCO3] < 15 and > 30 mmol/L in the latest determination, within the 6 weeks prior to enrollment.
- One or more pre-dialysis urea concentration <10 mmol/L or >30mmol/L within the 6 weeks prior to enrollment.
- Subjects requiring UF volume >2.0L per 2hr treatment in any dialysis session within 6 weeks prior to enrollment.
- Any documented episode of hemolysis within the 6 months prior to enrolment.
- Any infection related to the vascular access within the 4 weeks prior to enrolment.
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- History of impaired liver function (normal Factor V).
- Severe uncontrolled arterial hypertension (systolic BP>180mmHg or diastolic BP >104 mmHg).
- Known chronic obstructive pulmonary disease.
- Anticipation of a living donor kidney transplantation within the 2 months of the study period.
- Pregnant, breast feeding, or planning a pregnancy during the study period.
- 13. Any known psychosocial problems which may negatively influence dialysis treatment.
- 14. History of drug and/or alcohol abuse within the last 3 months prior to enrolment.
- 15. Patients with any serious medical condition which in the opinion of the investigator, may adversely affect the safety of the participant and/or effectiveness of the study
Trial locations and contacts
1 site in 1 country.
About this study
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.
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:
Read more
- 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
- End Stage Renal Disease, ESRD
- Being tested
- NeoKidney
- Keywords
- Dialysis, Hemodialysis, Sorbent, Short daily hemodialysis, SDHD, HD, ESRD, End stage renal disease, Dialysate
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeoKidneyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| NeoKidney therapy | Experimental | 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. Receives: Device: NeoKidney |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Through the end of last patient follow-up visit, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start11 Mar 2024
- Primary completion23 Jul 2024
- Study completion23 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nextkidney S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Monitoring Force Group
- Responsible party
- Sponsor
- Investigators
- Maxence Ficheux, Dr, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024135
- Sponsor's protocol ID
- NKH-CI22-01
- Acronym
- FIH Caen
- Status last verified
- Oct 2026
- First submitted
- 16 Aug 2023
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06024135
- Acronym / sponsor ID
- FIH Caen / NKH-CI22-01
- Conditions
- End Stage Renal Disease, ESRD
- Keywords
- Dialysis, Hemodialysis, Sorbent, Short daily hemodialysis, SDHD, HD, ESRD, End stage renal disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Nextkidney S.A.Industry (pharma, biotech, devices)
- Collaborators
- Monitoring Force Group
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 23 Jul 2024 (actual)
- Study completion
- 23 Jul 2024 (actual)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NeoKidney therapy | Experimental | Device: NeoKidneyEvery 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female aged 18 years or over;
- Treated with short-daily hemodialysis (1.5-3 h sessions) 5-6 times a week for at least 3 months;
- Estimated Urea removal concentration between [220 to 550] mmol. (Estimation based on the formula: ([Dry Weigh in kg]*] x 0,6)*([) x ([Last pre-dialysis urea concentration in mmol/L]*] x 0,5).
- Well-functioning vascular access (native fistula or graft or permanent veinous catheter) defined as:
- For females of reproducible age, negative urinary pregnancy test and use of appropriate birth control method(s);
Key exclusion criteria (14 listed)
- Post-dialysis body weight below 41.0 kg
- Hb <10.0 g/L, or pre-dialysis [Na] < 132 and > 145 mmol/L, pre-dialysis [K] < 3.5 and > 6 mmol/L and pre-dialysis [HCO3] < 15 and > 30 mmol/L in the latest determination, within the 6 weeks prior to enrollment.
- One or more pre-dialysis urea concentration <10 mmol/L or >30mmol/L within the 6 weeks prior to enrollment.
- Subjects requiring UF volume >2.0L per 2hr treatment in any dialysis session within 6 weeks prior to enrollment.
- Any documented episode of hemolysis within the 6 months prior to enrolment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeoKidneyProgressive 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. | Device | NeoKidney therapy |
Primary outcome
Absence of serious adverse events (SAE) and of serious adverse device effects (SADE).
Time frame: Through the end of last patient follow-up visit, an average of 2 months
To assess the safety of the NeoKidney in a small number (n=3) of patients and HD sessions (9 sessions per patient).
Absence of critical change in patient's blood pressure (mm Hg) during treatment
Time frame: Through the end of last patient follow-up visit, an average of 2 months
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).
Absence of critical change in patient's heart rate (bpm) during treatment
Time frame: Through the end of last patient follow-up visit, an average of 2 months
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).
Absence of critical change in patient's body temperature (°C) during treatment
Time frame: Through the end of last patient follow-up visit, an average of 2 months
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).
Absence of critical change in patient's pulse oximetry (% SpO2) during treatment
Time frame: Through the end of last patient follow-up visit, an average of 2 months
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).
Absence of critical change in bicarbonates (mmol/L) pre- vs post-treatment
Time frame: Through the end of last patient follow-up visit, an average of 2 months
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).
Absence of critical change in pH pre- vs post-treatment
Time frame: Through the end of last patient follow-up visit, an average of 2 months
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).
Absence of critical change in LDH (UI/L) pre- vs post-treatment
Time frame: Through the end of last patient follow-up visit, an average of 2 months
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).
Absence of critical change in Haptoglobin (g/L) pre- vs post-treatment
Time frame: Through the end of last patient follow-up visit, an average of 2 months
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).
Absence of critical change in Sodium (mmol/L) pre- vs post-treatment
Time frame: Through the end of last patient follow-up visit, an average of 2 months
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).
Absence of critical change in Potassium (mmol/L) pre- vs post-treatment
Time frame: Through the end of last patient follow-up visit, an average of 2 months
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).
Absence of critical change in Phosphate (mmol/L) pre- vs post-treatment
Time frame: Through the end of last patient follow-up visit, an average of 2 months
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).
Absence of critical change in Calcium (mmol/L) pre- vs post-treatment
Time frame: Through the end of last patient follow-up visit, an average of 2 months
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).
Absence of critical change in Chlorine (mmol/L) pre- vs post-treatment
Time frame: Through the end of last patient follow-up visit, an average of 2 months
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).
Absence of critical change in Magnesium (mmol/L) pre- vs post-treatment
Time frame: Through the end of last patient follow-up visit, an average of 2 months
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).
Absence of critical change in Magnesium (µmol/L) pre- vs post-treatment
Time frame: Through the end of last patient follow-up visit, an average of 2 months
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maxence Ficheux, Dr principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeoKidney in people with End Stage Renal Disease and ESRD, run by Nextkidney S.A. at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of serious adverse events (SAE) and of serious adverse device effects (SADE). (time frame: Through the end of last patient follow-up visit, an average of 2 months). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.