Second Clinical Evaluation of THERANOVA-500 Dialyzer in Chronic Hemodialysis (HD)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Post-dialysis recovery time (intervention period)
研究概览
简要总结
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).
详细描述
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:
- 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),
- Post-hemodialysis recovery time difference (mean between blinded and non-blinded THERANOVA-500 treated subjects during the 6-week intervention period,
- Post-hemodialysis recovery time difference (mean between blinded and non-blinded REVACLEAR-400 treated subjects during the 6-week intervention period),
- Post-hemodialysis recovery time difference mean gap between secondary endpoints 2 and 3,
- Percentage of subjects who report no (zero) recovery time (mean THERANOVA-500 vs mean REVACLEAR-400) during 6-week intervention period (all subjects),
- 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),
- 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),
- 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),
- 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),
- 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),
- 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),
- 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),
- 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),
- 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),
- 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),
- 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),
- 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),
- 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),
- 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),
- Subjects's QoL questionnaire fill preference (adapted KD QoL-SF vs EQ-5D vs rESAS) at study week 8.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
blinded group: as dialyzers are almost identical except for their labels, blinding is achieved by masking dialyzer labels.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18 years, all genders.
- •HD at DrGLDUHC for more than 3 months, 3 times/week schedule, and using REVACLEAR-
- •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.
排除标准
- •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.
结局指标
主要结局
Post-dialysis recovery time (intervention period)
时间窗: through 6-week intervention period
All subjects are asked weekly on their mid-week session how long did it take them to recover from their previous hemodialysis session for the entire duration of the project (10 weeks). Mean post-dialysis recovery time report (in hours) of all subjects on THERANOVA-500 (5 reports/subject) compared to mean of all subjects on REVACLEAR-400 reports during the 6-week intervention period (5 reports/subject) is the primary outcome measure.(intended statistical test: 2-sample t-Test)(re continuous data, n=35/group)
次要结局
- Post-hemodialysis recovery time change (THERANOVA-500 vs REVACLEAR-400)(through 10-week study)
- Percentage of subjects who report no (zero) recovery time (THERANOVA-500 vs REVACLEAR-400)(through 6-week intervention period)
- Pre and post 6-week intervention period pre-dialysis levels of interleukine-6(6 weeks)
- Quality of life (QoL) change (pre and at 2 weeks of intervention period)(adapted KDQoL-SF)(2 weeks)
- Quality of life (QoL) change (pre and at 2 weeks of intervention period)(EQ-5D)(2 weeks)
- Quality of life (QoL) change (pre and at 2 weeks of intervention period)(rESAS)(2 weeks)
- Post-hemodialysis recovery time difference mean gap (THERANOVA-500 vs REVACLEAR-400)(through 6-week intervention period)
- Pre and post 6-week intervention period pre-dialysis levels of free light chains(6 weeks)
- Pre and post 6-week intervention period pre-dialysis levels of C reactive protein(6 weeks)
- Pre and post 6-week intervention period pre-dialysis levels of procalcitonin(6 weeks)
- Quality of life (QoL) change (at 4 weeks of intervention period and week 8 of study)(EQ-5D)(4 weeks)
- Post-hemodialysis recovery time difference (THERANOVA-500)(through 6-week intervention period)
- Pre and post 6-week intervention period pre-dialysis levels of beta-2 microglobulin(6 weeks)
- Post-hemodialysis recovery time difference (REVACLEAR-400)(through 6-week intervention period)
- Quality of life (QoL) change (at 4 weeks of intervention period and week 8 of study)(adapted KDQoL-SF)(4 weeks)
- Quality of life (QoL) change (pre and at 4 weeks of intervention period)(EQ-5D)(4 weeks)
- Subjects's QoL questionnaire fill preference(at week 10 of study)
- Quality of life (QoL) change (pre and at 4 weeks of intervention period)(adapted KDQoL-SF)(4 weeks)
- Quality of life (QoL) change (pre and at 4 weeks of intervention period)(rESAS)(4 weeks)
- Quality of life (QoL) change (at 4 weeks of intervention period and week 8 of study)(rESAS)(4 weeks)