Safety and Efficacy Assessments of NeoKidney® in ESRD Patients Treated With Short Daily Hemodialysis

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:

• 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.

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