Clinical trial NCT06024135: Safety and Efficacy Assessments of NeoKidney® in ESRD Patients Treated With Short Daily Hemodialysis
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: End Stage Renal Disease
ESRD
Keywords: Dialysis
Hemodialysis
Sorbent
Short daily hemodialysis
SDHD
HD
ESRD
End stage renal disease
Dialysate
Lead sponsor: Nextkidney S.A.
Sponsor class: INDUSTRY
Collaborators: name: Monitoring Force Group
First posted: 2023-09-06
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Male or female aged 18 years or over;
2. Treated with short-daily hemodialysis (1.5-3 h sessions) 5-6 times a week for at least 3 months;
3. 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).
4. 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
5. For females of reproducible age, negative urinary pregnancy test and use of appropriate birth control method(s);
6. Ability to understand the informed consent and give informed consent;
7. Willingness and ability to comply with study procedures and to attend all study follow up visits

Exclusion Criteria:

1. Post-dialysis body weight below 41.0 kg
2. 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.
3. One or more pre-dialysis urea concentration \<10 mmol/L or \>30mmol/L within the 6 weeks prior to enrollment.
4. Subjects requiring UF volume \>2.0L per 2hr treatment in any dialysis session within 6 weeks prior to enrollment.
5. Any documented episode of hemolysis within the 6 months prior to enrolment.
6. Any infection related to the vascular access within the 4 weeks prior to enrolment.
7. History of impaired liver function (normal Factor V).
8. Severe uncontrolled arterial hypertension (systolic BP\>180mmHg or diastolic BP \>104 mmHg).
9. Known chronic obstructive pulmonary disease.
10. Anticipation of a living donor kidney transplantation within the 2 months of the study period.
11. 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

Primary outcomes:
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU de Caen
state: Normandie
Study officials:
affiliation: University Hospital, Caen
name: Maxence Ficheux, Dr
role: PRINCIPAL_INVESTIGATOR
References: