Second Clinical Evaluation of THERANOVA-500 Dialyzer in Chronic Hemodialysis (HD)

This is a randomized controlled trial involving 70 subjects divided in 4 groups: 25 single blinded subjects using THERANOVA‐500 dialyzer enabling Expanded Hemodialysis (HDx) ; 25 single blinded subjects using REVACLEAR‐400 dialyzer enabling conventional hemodialysis (HD); 10 non‐blinded subjects using THERANOVA‐500 enabling Expanded Hemodialysis (HDx) and 10 non‐blinded subjects using REVACLEAR‐400 dialyzer enabling conventional hemodialysis (HD) for their chronic hemodialysis treatments over an active intervention period of 6 weeks. All subjects are to be dialyzed using REVACLEAR‐400 enabling conventional hemodialysis (HD) for two weeks prior and for two weeks after the intervention period. Primary endpoint is mean post‐hemodialysis recovery time (as reported by subjects once weekly) between groups (THERANOVA‐500 vs REVACLEAR‐400) (all subjects) during the 6‐week intervention period. Secondary endpoints are: 1. Post‐hemodialysis recovery time change (mean of 2‐week pre and 2‐week post intervention period compared to mean during 6‐week intervention period)(mean THERANOVA‐500 vs mean REVACLEAR‐400)(all subjects), 2. Post‐hemodialysis recovery time difference (mean between blinded and non‐blinded THERANOVA‐500 treated subjects during the 6‐week intervention period, 3. Post‐hemodialysis recovery time difference (mean between blinded and non‐blinded REVACLEAR‐400 treated subjects during the 6‐week intervention period), 4. Post‐hemodialysis recovery time difference mean gap between secondary endpoints 2 and 3, 5. Percentage of subjects who report no (zero) recovery time (mean THERANOVA‐500 vs mean REVACLEAR‐400) during 6‐week intervention period (all subjects), 6. Pre and post 6‐week intervention period pre‐dialysis difference levels of beta‐2 microglobulin (mean THERANOVA‐500 vs mean REVACLEAR‐400)(all subjects)(in nmol/L), 7. Pre and post 6‐week intervention period pre‐dialysis difference levels of procalcitonin (mean THERANOVA‐500 vs mean REVACLEAR‐400)(all subjects)(in ng/ml), 8. Pre and post 6‐week intervention period pre‐dialysis difference levels of free light chains (gamma and lambda)(mean THERANOVA‐500 vs mean REVACLEAR‐400)(all subjects)(in mg/L), 9. Pre and post 6‐week intervention period pre‐dialysis difference levels of interleukine‐6 (mean THERANOVA‐500 vs mean REVACLEAR‐400)(all subjects)(in pg/ml), 10. Pre and post 6‐week intervention period pre‐dialysis difference levels of C reactive protein (CRP)(mean THERANOVA‐500 vs mean REVACLEAR‐400)(all subjects)(in mg/L), 11. Quality of life change (pre and at 2 weeks of intervention period) (mean THERANOVA‐500 vs mean REVACLEAR‐400)(all subjects)(assessed by adapted KDQoL‐SF questionnaire)(max score 130), 12. Quality of life change (pre and at 4 weeks of intervention period) (mean THERANOVA‐500 vs mean REVACLEAR‐400)(all subjects) assessed by adapted KDQoL‐SF questionnaire)(max score 130), 13. Quality of life change (at 4 weeks of intervention period and week 8 of study)(mean THERANOVA‐500 vs mean REVACLEAR‐400)(all subjects) assessed by adapted KDQoL‐SF (max score 130), 14. Quality of life change (pre and at 2 weeks of intervention period)(mean THERANOVA‐500 vs mean REVACLEAR‐400)(all subjects)(assessed by EQ‐5D questionnaire)(max score 125), 15. Quality of life change (pre and at 4 weeks of intervention period)(mean THERANOVA‐500 vs mean REVACLEAR‐400)(all subjects)(assessed by EQ‐5D questionnaire)(max score 125), 16. Quality of life change (at 4 weeks of intervention period and week 8 of study)(mean THERANOVA‐500 vs mean REVACLEAR‐400)(all subjects)(assessed by EQ‐5D questionnaire (max score 125), 17. Quality of life change (pre and at 2 weeks of intervention period (mean THERANOVA‐500 vs mean REVACLEAR‐400)(all subjects)(assessed by rESAS)(max score 100), 18. Quality of life change (pre and at 4 weeks of intervention period (mean THERANOVA‐500 vs mean REVACLEAR‐400)(all subjects)(assessed by rESAS)(max score 100), 19. Quality of life change (at 4 weeks of intervention period and week 8 of study)(mean THERANOVA‐500 vs mean REVACLEAR‐400)(all subjects)(assessed by rESAS)(max score 100), 20. Subjects's QoL questionnaire fill preference (adapted KD QoL‐SF vs EQ‐5D vs rESAS) at study week 8.