Efficacy of pHA130 Hemoadsorption on Protein-Bound Uremic Toxins and Quality of Life in Kidney Failure (PHOENIX)
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Jian Lu, PhD
- 電話番号：+8619834515101
- メール：lujiandr@163.com
研究連絡先のバックアップ
- 名前：Shimin Jiang, PhD
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：HAHD Group
Participants assigned to this group will receive a combination of hemodialysis (HD) and hemoadsorption (HA) therapy.
|
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.
|
|
アクティブコンパレータ：HD Group
Participants assigned to this group will receive standard maintenance hemodialysis therapy.
|
Patients receive conventional high-flux hemodialysis (HD) three times a week.
Each treatment session lasts for 4 hours.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Reduction Ratio from baseline in Serum Indoxyl Sulfate (IS) and p-Cresol Sulfate (PCS) Concentration
時間枠：Baseline, 3, 6, 9, 12 Months
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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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline in Health-Related Quality of Life (HRQoL)
時間枠：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
|
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Change from baseline in Cognitive Function
時間枠：Baseline, 3, 6, 9, 12 Months
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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
|
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Progression of Coronary Artery Calcification (CAC)
時間枠：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.
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Baseline, 6, 12 Months
|
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All-Cause Mortality
時間枠：Up to 12 Months
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Number of deaths from any cause during the study period.
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Up to 12 Months
|
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Incidence of Major Adverse Cardiovascular Events (MACEs)
時間枠：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
|
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Incidence of Adverse Events
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Wenge Li, MD、China-Japan Friendship Hospital
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2025-KY-177-1
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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