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Efficacy of pHA130 Hemoadsorption on Protein-Bound Uremic Toxins and Quality of Life in Kidney Failure (PHOENIX)

2026年6月22日 更新者：Wenge Li, MD, PhD、China-Japan Friendship Hospital

A Prospective, Multicenter, Randomized Controlled Trial of HAHD With pHA130 Cartridge vs. Conventional High-Flux HD for Clearance of Protein-Bound Uremic Toxins and Quality of Life Improvement in Kidney Failure.

Patients on maintenance hemodialysis (MHD) face a high risk of cardiovascular mortality and reduced quality of life. Conventional high-flux hemodialysis (HD) is the standard of care but has limited efficacy in clearing middle-molecular and protein-bound uremic toxins (PBUTs). The accumulation of these toxins is associated with adverse long-term outcomes.

This study evaluates the efficacy and safety of the pHA130 hemoadsorption cartridge, which utilizes a modified resin for enhanced PBUT adsorption, when combined with hemodialysis (HAHD). This is a prospective, open-label, multi-center, randomized controlled trial involving 100 MHD patients. Participants will be randomized 1:1 to either the HAHD group (receiving one HAHD session using the pHA130 cartridge and two standard HD sessions weekly) or the Control group (receiving three standard HD sessions weekly).

The primary objective is to assess the reduction in serum indoxyl sulfate (IS) and p-cresol sulfate (PCS) levels from baseline to 12 months. Secondary objectives include evaluating changes in quality of life (KDQoL-SF, MMSE), the progression of coronary artery calcification (CAC), the incidence of major adverse cardiovascular events (MACEs), all-cause mortality, and safety profiles. This trial aims to determine if integrating long-term HAHD therapy can optimize blood purification strategies for the MHD population.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Patients with chronic kidney disease (CKD), particularly those on maintenance hemodialysis (MHD), face a high burden of cardiovascular disease and significantly impaired health-related quality of life. Traditional hemodialysis (HD) and hemodiafiltration (HDF) are effective at clearing small water-soluble molecules, but their efficacy in removing protein-bound uremic toxins (PBUTs)-such as indoxyl sulfate (IS) and p-cresyl sulfate (PCS)-is notably limited. The accumulation of PBUTs is strongly associated with vascular calcification, increased cardiovascular mortality, and severe symptoms like uremic pruritus.

Hemoadsorption combined with hemodialysis (HAHD) has emerged as a promising strategy to address this gap. The novel pHA130 hemoadsorption cartridge features a modified resin with micro-controlled positive charges, enhancing its targeted adsorption capacity for PBUTs through electrostatic, hydrophobic, and molecular sieving mechanisms. In vitro studies have shown IS and PCS clearance rates exceeding 90%.

The PHOENIX trial is a prospective, open-label, multicenter, randomized controlled trial designed to evaluate the long-term clinical efficacy and safety of the pHA130 cartridge in MHD patients. Following a 4-week run-in period, eligible participants will be randomized 1:1 into two arms:

Experimental Group (HAHD): Receives high-flux HD twice a week and HAHD once a week. During HAHD, the pHA130 cartridge is placed in series before the high-flux dialyzer.

Control Group (HD): Receives conventional high-flux HD three times a week.

The primary endpoint is the percentage reduction in serum IS and PCS concentrations from baseline to 12 months. Secondary endpoints include changes in health-related quality of life (assessed by KDQoL-SF) and cognitive function (assessed by MMSE), progression of coronary artery calcification (CAC) measured by Agatston score, incidence of major adverse cardiovascular events (MACEs), all-cause mortality, and safety metrics. The results of this study aim to provide robust evidence for optimizing blood purification strategies and improving long-term outcomes for patients with end-stage renal disease.

研究类型

介入性

注册 (估计的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名：Shimin Jiang, PhD

学习地点

  • 中国
      • Beijing、中国
        • 招聘中
        • China-Japan Friendship Hospital
        • 接触：
          • Jian Lu

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Age > 18 years.
  • On maintenance hemodialysis for > 3 months.
  • Receiving hemodialysis 3 times per week, 4 hours per session.
  • Standard Kt/V ≥ 1.2.
  • Voluntarily participates and provides written informed consent.

Exclusion Criteria:

  • Known allergy to the dialyzer or hemoperfusion device.
  • Platelet count < 60×10⁹/L.
  • Serum albumin < 30 g/L.
  • 24-hour urine output > 200 ml.
  • Inability to achieve a blood flow rate ≥ 200 ml/min.
  • Coagulation disorders, severe bleeding tendency, or active bleeding.
  • Pre-dialysis systolic blood pressure < 90 mmHg or diastolic blood pressure < 60 mmHg.
  • Active malignancy.
  • Active infection, or severe, critical illness of cardiac, pulmonary, hepatic, or nervous systems.
  • Planned living-donor kidney transplant within the next 6 months.
  • Current participation in another interventional clinical study, or participation within the past 3 months in an interventional study that may interfere with the present study (e.g., fecal microbiota transplantation); or use of intestinal microecological regulators such as probiotics.
  • History of unstable angina, myocardial infarction, malignant arrhythmia, cardiac or peripheral vascular surgery, or cerebrovascular accident within the past 8 weeks.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：HAHD Group
Participants assigned to this group will receive a combination of hemodialysis (HD) and hemoadsorption (HA) therapy.
设备：pHA130 Hemoadsorption Cartridge
Following a 4-week run-in period,patients receive High-flux hemodialysis (HD) twice a week and combined HAHD once a week. During the HAHD session, the pHA130 hemoadsorption cartridge is placed in series with a high-flux dialyzer. Each treatment session lasts for 4 hours.
有源比较器：HD Group
Participants assigned to this group will receive standard maintenance hemodialysis therapy.
设备：High-flux Hemodialyzer
Patients receive conventional high-flux hemodialysis (HD) three times a week. Each treatment session lasts for 4 hours.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Reduction Ratio from baseline in Serum Indoxyl Sulfate (IS) and p-Cresol Sulfate (PCS) Concentration
大体时间：Baseline, 3, 6, 9, 12 Months
Percentage reduction in serum IS and PCS concentration from baseline after 12 months of treatment, measured by High-Performance Liquid Chromatography (HPLC).
Baseline, 3, 6, 9, 12 Months

次要结果测量

结果测量
措施说明
大体时间
Change from baseline in Health-Related Quality of Life (HRQoL)
大体时间：Baseline, 3, 6, 9, 12 Months
Health-Related Quality of Life (HRQoL) is assessed using the Kidney Disease Quality of Life Short Form (KDQOL-SF). The KDQOL-SF scores range from a minimum of 0 to a maximum of 100. A higher score indicates a better health-related quality of life.
Baseline, 3, 6, 9, 12 Months
Change from baseline in Cognitive Function
大体时间：Baseline, 3, 6, 9, 12 Months
Cognitive function is assessed using the Mini-Mental State Examination (MMSE). The MMSE total score ranges from a minimum of 0 to a maximum of 30. A lower score indicates more severe cognitive impairment (i.e., a higher score reflects better cognitive function).
Baseline, 3, 6, 9, 12 Months
Progression of Coronary Artery Calcification (CAC)
大体时间：Baseline, 6, 12 Months
Coronary Artery Calcification (CAC) progression is assessed by measuring the change in the Agatston score using Computed Tomography (CT) scans. The Agatston score has a minimum value of 0, with no defined maximum upper limit. A higher score indicates a greater burden of coronary artery calcification and a higher cardiovascular risk.
Baseline, 6, 12 Months
All-Cause Mortality
大体时间：Up to 12 Months
Number of deaths from any cause during the study period.
Up to 12 Months
Incidence of Major Adverse Cardiovascular Events (MACEs)
大体时间：Up to 12 Months
MACEs are defined as a composite of non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death.
Up to 12 Months
Incidence of Adverse Events
大体时间：Baseline, 3, 6, 9, 12 Months
Safety will be evaluated by monitoring and recording the incidence, severity, and relationship to the intervention of any adverse events (AEs) or serious adverse events (SAEs) throughout the study period.
Baseline, 3, 6, 9, 12 Months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

China-Japan Friendship Hospital

合作者

Zhuhai Hospital of Integrated Traditional Chinese and Western Medicine

调查人员

  • 首席研究员：Wenge Li, MD、China-Japan Friendship Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月1日

初级完成 (估计的)

2028年4月1日

研究完成 (估计的)

2028年8月1日

研究注册日期

首次提交

2026年5月9日

首先提交符合 QC 标准的

2026年6月14日

首次发布 (实际的)

2026年6月18日

研究记录更新

最后更新发布 (实际的)

2026年6月25日

上次提交的符合 QC 标准的更新

2026年6月22日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2025-KY-177-1

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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