second clinical evaluation of theranova-500 dialyzer in chronic hemodialysis (hd)

Conditions: End Stage Renal Disease on Dialysis

Summary: single blinded randomized controlled trial comparing expanded hemodialysis (hdx) using theranova-500 dialyzer versus conventional hemodialysis (hd) using revaclear-400 dialyzer in chronic hemodialysis patients over a 6-week intervention period. primary endpoint is post-hemodialysis recovery time. secondary endpoints are six pre-dialysis biomarker levels (b2-microglobuline, procalcitonine, free light chains (gamma-lambda), il-6, crp) and three quality of life (qol)(adapted kdqol-sf questionnaire, eq-5d, and resas).

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.

Eligibility criteria:
inclusion criteria: * age greater than 18 years, all genders. * hd at drglduhc for more than 3 months, 3 times/week schedule, and using revaclear-400. * good vascular access (blood flow (qb) \> 300 during entire previous 6 hd sessions, no per-hd alteplase treatments used over the last 2 weeks, routine alteplase-lock allowed) * signed informed consent * likely to be able to participate for the duration of the clinical evaluation (no trips, no elective procedures, no transfer to another dialysis modality or hd facility, etc). * able to fill questionnaires, staff assistance allowed. exclusion criteria: * hd more than 3 times/week * hd on other dialyzers than revaclear-400 * poor vascular access (from staff and nephrologists' evaluation) * no consent or unable to answer questionnaires even with staff assistance.