Study Inclusion Criteria
A subject must meet ALL of the following criteria in order to participate:
- Signed and dated written Informed Consent Form obtained from the subject or his/her guardian or in accordance with local regulations.
- Male or female aged ≥ 18 years.
- Diagnosed with ESKD.
- Established on haemodialysis for 3 months or longer.
- Likely to achieve high-dose HDF (≥ 23 L in post-dilution mode), according to the protocol (Appendix I).
- Willing to have a dialysis session with duration of ≥ 4 hours, three times a week.
- Understands study procedures and is able to comply.
Study Exclusion Criteria
A subject who meets any of the following criteria will be excluded from participation:
- Severe subject non-compliance defined as severe non-adherence to the dialysis procedure and accompanying prescriptions, especially frequency and duration of dialysis treatment.
- Life expectancy < 3 months.
- HDF treatment < 90 days before screening.
- Anticipated living donor kidney transplantation < 6 months after screening.
- Evidence of any other diseases or medical conditions that may interfere with the planned treatment, affect subject compliance or place the subject at high risk for treatment-related complications.
- Participation in any other study will be discussed with and decided by the Executive Board depending on the extent of interference on this study. Registries are expected to be approved.
- Unavailable ≥ 3 months during the study conduct for study visits.