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Идёт набор NCT07111260

Efficacy of pHA130 Hemoadsorption for 4 Hours (p4H Study)

Без фазы С лечением End Stage Renal Disease on Dialysis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: pHA130 Hemoadsorption + High-Flux Hemodialysis.
Кому может быть актуально
Состояния в реестре: End Stage Renal Disease on Dialysis. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Comparison of the Efficacy of Hemoadsorption Combined With Hemodialysis of Different Treatment Durations in Clearing Protein-Bound Uremic Toxins: A Randomized Crossover Controlled Trial

Обзор

This is an open-label, randomized, crossover study to evaluate the efficacy of extending the duration of hemoadsorption (HA) combined with hemodialysis (HD) from 2 hours to 4 hours for clearing protein-bound uremic toxins, such as Indoxyl Sulfate (IS), in stable maintenance hemodialysis patients. Patients will be randomized to receive either 2-hour HA or 4-hour HA once a week for 8 weeks, then cross over to the other treatment for another 8 weeks after a 2-week washout period. The primary endpoint is the reduction rate of IS.

Подробное описание

Patients with end-stage renal disease (ESRD) on maintenance hemodialysis (MHD) have a high burden of uremic toxins, particularly protein-bound uremic toxins (PBUTs), which are poorly cleared by conventional dialysis and are associated with high cardiovascular mortality. hemoadsorption (HA) is an adjunctive blood purification technique effective at removing PBUTs. The standard duration for HA sessions is typically 2-2.5 hours. However, emerging evidence suggests that extending the treatment duration may enhance toxin removal. This study aims to rigorously compare the efficacy and safety of a 4-hour HA session combined with hemodialysis against a standard 2-hour session in clearing key PBUTs like Indoxyl Sulfate (IS) and p-Cresyl Sulfate (PCS). The findings will provide crucial evidence for optimizing HA treatment protocols to improve toxin clearance and potentially patient outcomes in the ESRD population.

Вмешательства

  • Устройство pHA130 Hemoadsorption + High-Flux Hemodialysis
    A combination blood-purification procedure in which a pHA130 hemoperfusion cartridge is connected in series with a high-flux hemodialyzer. Blood first passes through the HP cartridge to adsorb protein-bound uremic toxins and is then dialyzed. In the 4-hour arm the HP cartridge remains online for the entire 4-hour session; in the 2-hour arm the cartridge is removed after 2 hours and dialysis continues alone for the remaining 2 hours. Blood-flow rates are 250-350 mL/min (4-hour arm) or 200-250 mL/

Первичные конечные точки

  • Reduction Rate of Serum Indoxyl Sulfate (IS) [Срок оценки: At Week 1, Week 8, Week 11, and Week 18; blood samples will be collected at 0 hours (before treatment), 2 hours after treatment begins, and 4 hours (end of treatment) during each visit]
Вторичные конечные точки (5)
  • Reduction Rate of p-Cresyl Sulfate (PCS) [Срок оценки: At Week 1, Week 8, Week 11, and Week 18; blood samples will be collected at 0 hours (before treatment), 2 hours after treatment begins, and 4 hours (end of treatment) during each visit]
  • Change from Baseline in Pre-dialysis IS levels [Срок оценки: Baseline (Week 1) to end of period 1 (Week 8); Baseline of period 2 (Week 11) to end of period 2 (Week 18)]
  • Change from Baseline in Pre-dialysis PCS levels [Срок оценки: Baseline (Week 1) to end of period 1 (Week 8); Baseline of period 2 (Week 11) to end of period 2 (Week 18)]
  • Clearance of Other Uremic Toxins [Срок оценки: Week 1, Week 8, Week 11, Week 18]
  • Number of Participants With Adverse Events, Circuit Coagulation, and Abnormal Changes in Vital Signs or Laboratory Parameters [Срок оценки: Throughout the entire study duration (up to 18 weeks)]

Критерии участия

Критерии включения

  • Age between 18 and 75 years, regardless of gender
  • Stable maintenance hemodialysis for ≥3 months, with a relatively fixed dialysis regimen
  • Receiving hemodialysis 3 times per week, each session lasting ≥4 hours
  • Single-pool Kt/V (spKt/V) ≥1.2 within 8 weeks prior to enrollment
  • Willing and able to sign the informed consent form

Критерии исключения

  • Life expectancy less than 1 year
  • White blood cell count < 4 × 10⁹/L and/or platelet count < 60 × 10⁹/L
  • Active or chronic gastrointestinal bleeding, or diagnosed coagulation disorders
  • Active malignant tumor
  • Active infection
  • Pregnant or breastfeeding
  • Participation in another clinical trial within the past month or currently enrolled in one
  • Deemed unsuitable for the study by the investigator

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Peking University People's Hospital — Пекин

Идентификаторы

NCT: NCT07111260 · 2025PHB095-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗