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

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 onthe formula: ([Dry Weigh in kg]] x 0,6)([) x ([Last pre-dialysis urea concentrationin mmol/L]*] x 0,5).
4. Well-functioning vascular access (native fistula or graft or permanent veinouscatheter) 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 ofappropriate 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 followup 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 weeksprior to enrollment.
4. Subjects requiring UF volume >2.0L per 2hr treatment in any dialysis session within 6weeks 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 >104mmHg).
9. Known chronic obstructive pulmonary disease.
10. Anticipation of a living donor kidney transplantation within the 2 months of the studyperiod.
11. Pregnant, breast feeding, or planning a pregnancy during the study period.
12. Any known psychosocial problems which may negatively influence dialysis treatment.
13. History of drug and/or alcohol abuse within the last 3 months prior to enrolment.
14. 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