Table 1

Inclusion and exclusion criteria for enrolment in CONVINCE

Inclusion criteriaA participant must meet ALL of the following criteria in order to participate:
  1. Signed and dated written Informed Consent Form obtained from the participant or his/her guardian or in accordance with local regulations.

  2. Aged ≥18 years.

  3. Diagnosed with ESKD.

  4. On HD treatment for ≥3 months.

  5. Likely to achieve high-dose HDF (≥23 L, in postdilution mode), according to the protocol.

  6. Willing to have a dialysis session with duration of ≥4 hours, three times a week.

  7. Understands study procedures and is able to comply.

Exclusion criteriaA participant who meets any of the following criteria will be excluded from participation:
  1. Severe participant non-compliance defined as severe non-adherence to the dialysis procedure and accompanying prescriptions, especially frequency and duration of dialysis treatment.

  2. Life expectancy <3 months.

  3. HDF treatment <90 days before screening.

  4. Anticipated living donor kidney transplantation <6 months after screening.

  5. Evidence of any other diseases or medical conditions that may interfere with the planned treatment, affect participant compliance or place the participant at high risk for treatment-related complications.

  6. Participation in any other study will be discussed with and decided by the Executive Board.

  7. Unavailable ≥3 months during the study conduct for study visits.

  • ESKD, end-stage kidney disease; HD, haemodialysis; HDF, haemodiafiltration.