Advancing Dialyzer Technology: Efficacy and Safety of Super High-Flux Hemodialysis in Maintenance Dialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from Baseline in α1-microglobulin (α1-MG) Reduction Ratio
研究概览
简要总结
Patients with end-stage kidney disease (ESKD) rely on maintenance hemodialysis. While high-flux hemodialysis improves small solute clearance, its removal of middle-molecule uremic toxins (e.g., α1-microglobulin [α1-MG]) remains insufficient, contributing to symptoms such as restless legs syndrome (RLS), pruritus, and poor sleep quality, which are also linked to increased cardiovascular risk. In this study, the investigators evaluate whether using a "Super High-Flux" dialyzer (a Type V high-performance dialyzer) during hemodialysis can safely improve the removal of middle-molecule uremic toxins-specifically α1-microglobulin (α1-MG)-and relieve RLS symptoms in maintenance hemodialysis patients.
详细描述
Patients with end-stage kidney disease (ESKD) on regular high-flux hemodialysis (HD) often experience an accumulation of middle-molecule uremic toxins, which are linked to systemic inflammation and troubling symptoms such as restless legs syndrome (RLS), severe itching, and poor sleep quality. While traditional high-flux dialysis efficiently clears small molecules, its ability to remove larger middle-molecule toxins (like α1-microglobulin [α1-MG]) is limited. Current alternatives such as online hemodiafiltration (HDF) have limitations, highlighting the need for new treatment approaches. Super High-Flux Hemodialysis (SHFHD) offers enhanced clearance of these middle molecules while preserving serum albumin levels and maintaining patient safety.
In this study, the investigators evaluate the effectiveness and safety of SHFHD compared with high-flux HD in patients undergoing maintenance HD, focusing on α1-MG removal and its potential effect on RLS. The investigators also explore the multiple diverse effects of SHFHD on the changes of cardiovascular risk factors including bone turnover, mineral metabolism, vascular calcification, uremia, inflammation, immunity, metabolomics, nutrition, and gut microbial metabolites in dialysis patients.
It is to conduct a randomized, controlled, crossover trial with cross-over design at a dialysis unit of tertiary teaching hospital in Northern Taiwan. The investigators will stratify participants by baseline RLS. Participants will receive either SHFHD or high-flux HD for 12 weeks, followed by a 4-week washout and crossover. The study outcome measures are difference in change-from-baseline values of α1-MG reduction ratio, RLS severity (International Restless Legs Scale), albumin levels, clearance of β2-microglobulin, free light chains, inflammatory markers, pruritus scores, and quality of life. Safety will be assessed via albumin maintenance, adverse events, and hemodynamic stability.
This will be the first RCT directly evaluating SHFHD for α1-MG removal and RLS outcomes, addressing critical knowledge gaps and potentially informing new dialysis prescription strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Laboratory technicians who assess the study outcomes will be masked
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Restless Legs Syndrome according to standard criteria.
- •Age ≥ 20 years.
- •Maintenance high-flux hemodialysis for ≥ 3 months.
- •Stable vascular access (AV fistula or AV graft).
- •Adequate dialysis delivery (URR ≥ 65% or Kt/V(daugirdes) ≥ 1.2).
- •Sufficient iron stores (serum ferritin ≥ 200 ng/mL, TSAT ≥ 20%).
- •Clinically stable condition for the past 4 weeks.
- •Able and willing to comply with study protocol
排除标准
- •Low-flux HD or temporary catheter use
- •Serum albumin < 2.5 g/dL
- •Recent hospitalization (within 4 weeks)
- •Scheduled kidney transplantation
- •Active malignancy or infection
- •Any condition impairing protocol adherence
研究组 & 干预措施
Super High-Flux HD
Receives 12 weeks of Super High-Flux HD (Elisio™-HX)
干预措施: Super High-Flux HD (Device)
High-Flux HD
Receives 12 weeks of High-Flux HD as usual care
结局指标
主要结局
Change from Baseline in α1-microglobulin (α1-MG) Reduction Ratio
时间窗: Baseline, Week 4, Week 8, and Week 12 of each 12-week treatment period
The reduction ratio of α1-MG will be calculated as \[({Pre-dialysis} - {Post-dialysis}) /{Pre-dialysis}\] at each study visit. The primary outcome is the difference in the change-from-baseline reduction ratio between the Super High-Flux HD period and the High-Flux HD period.
次要结局
- Change from Baseline in International Restless Legs Scale (IRLS) Score(Baseline, Week 4, Week 8, and Week 12 of each 12-week treatment period)
- Change from Baseline in Pre-dialysis Serum Albumin Level(Baseline, Week 4, Week 8, and Week 12 of each 12-week treatment period)
- Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score(Baseline, Week 4, Week 8, and Week 12 of each 12-week treatment period)
- Change from Baseline in 5-D Itch Scale Score(Baseline, Week 4, Week 8, and Week 12 of each 12-week treatment period)
- Change from Baseline in health-related quality of life (EQ-5D-5L) Score(Baseline, Week 4, Week 8, and Week 12 of each 12-week treatment period)
- Change from Baseline in β2-microglobulin [β2-MG] Reduction ratio(Baseline, Week 4, Week 8, and Week 12 of each 12-week treatment period)
- Change from Baseline in Kappa Free Light Chains Reduction ratio(Baseline, Week 4, Week 8, and Week 12 of each 12-week treatment period)
- Change from Baseline in Lambda Free Light Chains Reduction ratio(Baseline, Week 4, Week 8, and Week 12 of each 12-week treatment period)
- Change from Baseline in Pre-dialysis Serum interleukin-6 (IL-6) Level(Baseline, Week 4, Week 8, and Week 12 of each 12-week treatment period)
- Change from Baseline in Pre-dialysis Serum High-sensitivity C-reactive Protein (hs-CRP) Level(Baseline, Week 4, Week 8, and Week 12 of each 12-week treatment period)
- Change from Baseline in Pre-dialysis Serum Indoxyl Sulfate Level(Baseline, Week 4, Week 8, and Week 12 of each 12-week treatment period)
- Change from Baseline in Pre-dialysis Serum P-cresol Sulfate Level(Baseline, Week 4, Week 8, and Week 12 of each 12-week treatment period)
研究者
Wan-Chuan Tsai
M.D., Ph.D.; Attending Physician, Division of Nephrology; Director, Clinical Trials Center; Assistant Professor, Ministry of Education
Far Eastern Memorial Hospital