Convince Hemodiafiltration Dialysis Study


Entry Criteria

Information about the Convince study entry criteria.

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:

  1. Severe subject 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 subject compliance or place the subject at high risk for treatment-related complications.
  6. 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.
  7. Unavailable ≥ 3 months during the study conduct for study visits.
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