CONVINCE
Research type
Research Study
Full title
An international multi-centre, prospective randomised controlled study comparing high-dose haemodiafiltration (HDF) versus conventional high-flux haemodialysis (HD)
IRAS ID
243332
Contact name
Andrew Davenport
Contact email
Sponsor organisation
University Medical Centre Utrecht
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
End-stage kidney disease (ESKD) affects ~55,000 people in the UK, with ~7,000 newly affected people each year. It ranks among the most severe of the chronic non-communicable diseases. Morbidity is high, with dialysis patients in
the UK admitted to hospital on average ~1.5-2.0 times per year and spending ~15 days in hospital per year. Quality of life on dialysis is also well below that of the general population. There is therefore an unmet and urgent need toimprove ESKD patient treatment and quality of life.
Renal replacement therapy (dialysis or transplantation) is necessary when patients become symptomatic of ESKD. Currently ~90% of dialysis patients are on some form of haemodialysis (HD) or haemodiafiltration (HDF). Although HD and HDF can be performed at home, the majority is performed in-centre.
Treating the 25,000 people on HD costs around £500m of NHS spending each year, with a further £75m spent on hospital admissions and £50m on transport to and from dialysis. Half of patients now starting dialysis are 65 years or older and less likely to be fit for kidney transplantation and in the general population this group is predicted to increase by 60% (from 10.3m to 16.9m) by 2035. While preventing ESKD in the first place should remain a priority, the optimal form of dialysis will remain highly relevant to the NHS.
We aim to establish the effectiveness and cost-effectiveness of high-volume HDF compared with high-flux HD in adult patients with ESKD on maintenance thrice weekly in-centre HD. We will do this by running a randomised controlled trial using patient mortality as our primary outcome, and secondary outcomes including quality of life and health care economics.
Lay summary of study results: In this study, total of 1360 patients underwent randomisation: 683 received high-dose hemodiafiltration and 677 received high-flux hemodialysis. Death from any cause occurred in 118 patients (17.3%) in the hemodiafiltration group and in 148 patients (21.9%) in the hemodialysis group. This 4.6% difference represents a 23% reduction in the risk of death. In summary, in patients with kidney failure resulting in kidney-replacement therapy, the use of high-dose hemodiafiltration dialysis resulted in a lower risk of death from any cause than conventional high-flux hemodialysis.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
18/EM/0213
Date of REC Opinion
14 Aug 2018
REC opinion
Favourable Opinion