Aims and objectives

Aims of the CONVINCE Study

The CONVINCE study investigates whether haemodialysis or haemodiafiltration offers patients a better treatment, or whether treatments are equivalent. It will enrol a large number of kidney dialysis patients currently dialysing in Europe. It will also collect information about patients' quality of life, hospital admissions and patient survival.

How results will be used

• Collect data to conduct an economic evaluation of high-dose HDF compared to HD in patients with ESKD, to support Health Technology Assessment considerations among Member States and healthcare to facilitate patient acceptance and uptake of high-dose HDF across Europe.
• Develop best practices and new guidelines for doctors and dialysis centres on the most effective and efficient type of dialysis for patients with kidney failure.
• Disseminate, promote, and exploit results in close collaboration with all stakeholders and end-users. Establish a sound evidence and regulatory basis for the implementation of high-dose HDF across Europe, when and where proven superior as compared to conventional HD.

CONVINCE posits that HDF can replace HD as the primary therapy of choice for all ESKD patients. To this end, the CONVINCE consortium will pursue to prove the superiority of high-dose HDF as compared to high-flux HD (i.e. current standard of care) in terms of morbidity, mortality and Health-related Quality of Life (HRQL), by conducting a large, international, multi-centre, randomised controlled trial and use Patient Reported Outcome Measures (PROs) and Patient Reported Experience Measures (PREs) to capture.

Principal objectives

Compare high-dose haemodiafiltration with high-flux haemodialysis treatment in terms of all-cause mortality.

Endpoint

Defined as difference in rate for all-cause mortality.

Secondary objectives

• Compare high-dose high-dose haemodiafiltration with high-flux haemodialysis treatment in terms of cause specific morbidity and mortality.
• Assess patient reported outcome measures and patient reported experience measures to capture and patient perspectives and compare between high-dose haemodiafiltration with high-flux haemodialysis treatment.
• Assess cost effectiveness of high-dose haemodiafiltration compared to high-flux haemodialysis.

Endpoints

• Cause specific mortality (at least cardiovascular and non-cardiovascular death; others with high frequency may be added)
• Non-fatal and fatal cardiovascular events
• Hospitalisation for infection-related conditions
• All cause hospitalisations
• PREMS and PROMS
• Cost effectiveness.