end stage kidney disease hemodialysis hemodiafiltration
Conditions
Interventions
Usual care: Participants with ESKD who will be included will receive high-flux haemodialysis before randomisation. High-flux HD is defined as HD using high-flux dialysis membranes and bicarbonate base
Sponsors
University Medical Center Utrecht, Utrecht, The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: A 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. Male or female aged ≥ 18 years. 3. Diagnosed with ESKD. 4. On HD treatment for ≥ 3 months. 5. Likely to achieve high-dose HDF (≥ 23 L session, in post-dilution mode), according to the protocol (Appendix I). 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 criteria
Exclusion criteria: A 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 depending on the extent of interference on CONVINCE . Registries are expected to be approved. 7. Unavailable ¡Ý 3 months during the study conduct for study visits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is defined as difference in rate for all-cause mortality, analysed as the difference in mortality rate between the two treatment arms. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are (1) Cause specific mortality (at least cardiovascular and non-cardiovascular death; others with high frequency may be added); (2) non-fatal and fatal cardiovascular events; (3) hospitalisation for infection-related conditions; (3) All cause hospitalisations; (4) PREMS and PROMS; and (5) Cost effectiveness. | — |
Contacts
Public ContactP.J. Blankestijn
University Medical center Utrecht (UMCU), HP F03.223, P.O. Box 85500
Outcome results
None listed