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

Prior treatment

• 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.
• 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

Other illness

• 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.

Lab values

• 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.

Other

• Post-dialysis body weight below 41.0 kg

• 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
• 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