CONVINCE An international, multi-centre, prospective, randomised, controlled study comparing high-dose Haemodiafiltration (HDF) versus conventional high-flux Haemodialysis (HD).
- Conditions
- 10038430renal insufficiencyEnd Stage Kidney Disease
- Registration Number
- NL-OMON52958
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
1. Signed and dated written Informed Consent Form.
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 adjusted to BSA/session, in
post-dilution mode)
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is defined as difference in rate for all-cause mortality.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoints are:<br /><br>1. Cause specific mortality (at least cardiovascular and non-cardiovascular<br /><br>death; others with high frequency may be added);<br /><br>2. Non-fatal and fatal cardiovascular events;<br /><br>3. Hospitalisation for infection-related conditions;<br /><br>4. All cause hospitalisations;<br /><br>5. patient related experience and outcome measures;<br /><br>6. Cost effectiveness.</p><br>