Early Feasibility Study to Evaluate the Safety and Efficacy of PAK HD in ESRD Patients

Exclusion Criteria

• •1. Subjects with haemoglobin level of \<10.5g/dL in any measurement 2 months prior to enrolment.
• •2. Subjects with the following pre-dialysis serum values in any measurement 2 months prior to enrolment:
• •* sodium concentration \<132 mmol/L or \> 145mmol/L
• •* bicarbonate \<15mmol/L or \>30mmol/L
• •* plasma potassium concentration \<3.5mmol/L or \>5.8mmol/L
• •* urea \<15mmol/L or \>28 mmol/L
• •3. Subjects with severe hypertension: systolic blood pressure \> /=180 mmHg, diastolic blood pressure \>/=120 mmHg in any officemeasurement less than 4 weeks prior to enrolment.
• •4. Subjects with chronic obstructive pulmonary disease or any respiratory disease that may predispose to CO2 retention.
• •5. Subjects with impaired liver function. Impaired liver function is defined as an elevated ALT (alanine aminotransferase) by 3-fold orgreater above the upper limit of normal.
• •6. Subjects with episodes of haemolysis in any measurement 3 months prior to enrolment.
• •7. Subjects with a central venous catheter.
• •8. Subjects with vascular access dysfunction (whether or not requiring an intervention), i.e. failure to achieve and/ or sustain a bloodflow of \>/=250 mL/min and/or signs of compromised vascular access patency (according to the opinion of the investigator) within 4weeks prior to enrolment.
• •9. Subjects with vascular access related infection less than 4 weeks prior to enrolment
• •10. Subjects requiring an average ultrafiltration volume \>2.8 L per 4-h treatment in mid-week dialysis session in the past 4 weeks priorto enrolment.
• •11. Subjects who are on heparin free dialysis
• •12. Subjects who are unable to provide informed consent.
• •13. Subjects who are unable to comply with study procedures.
• •14. Subjects with psychosocial problems which may negatively influence dialysis treatment.
• •15. Subjects who participated in another clinical intervention or device trial less than 12 weeks prior to enrolment, are currentlyparticipating or intend to participate in such a trial.
• •16. Subjects who are pregnant, breast feeding, or planning a pregnancy within the study period.
• •17. Subjects with a life expectancy \<1 year.
• •18. Subjects who are anticipating a living donor kidney transplantation within \< 2 months of the study period.
• •19. Subjects with recent history of drug and/or alcohol abuse in the last 3 months prior to enrolment.