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Набор скоро начнётся NCT07565701

Safety and Efficacy of a Phased Transition From Epogen to Three Times Weekly Oral Vadadustat for the Treatment of Anemia in Subjects Receiving In-Center Hemodialysis

Фаза III С лечением Anemia Associated With Chronic Kidney Disease

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: Epoetin alga (Epogen)/vadadustat.
Кому может быть актуально
Состояния в реестре: Anemia Associated With Chronic Kidney Disease. Базовые параметры: от 18 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The goal of this study is to assess if patients can be retained on long-term vadadustat therapy (and thus potentially benefit from the favorable safety profile) by incorporating a phased transition from Epogen to three times per week vadadustat (TIW-V), reducing the likelihood of GI intolerance through use of a lower vadadustat starting dose, and also reducing or eliminating the initial reduction in hemoglobin through the maintenance of low dose Epogen until target hemoglobin stability is achieved on a tolerable dose of TIW-V.

Подробное описание

This is a multi-center, single-arm, open-label study assessing the safety of a phased transition from Epogen to three times per week vadadustat (TIW-V) for the treatment of anemia in subjects receiving in-center hemodialysis.

Subjects who have signed an IRB-approved informed consent form and who meet all of the inclusion criteria and none of the exclusion criteria will simultaneously have their Epogen dose reduced by 50% and initiate 300 mg vadadustat TIW.

Subsequent dose modifications will occur in order to target a narrow hemoglobin range (10-11 g/dL). Patients will have their hemoglobin assessed every 2 weeks and will continue in the trial for up to 28 weeks.

Вмешательства

  • Препарат Epoetin alga (Epogen)/vadadustat
    Phased transition from Epogen to three times weekly (TIW) oral vadadustat

Первичные конечные точки

  • Proportion of patients starting three times per week vadadustat (TIW-V) who remain on TIW-V at week 20 [Срок оценки: 20 weeks]
Вторичные конечные точки (2)
  • Proportion of patients starting three times per week vadadustat (TIW-V) who do not demonstrate a drop in Hgb >0.75 g/dL at any point from baseline to week 20 [Срок оценки: 20 weeks]
  • Proportion of patients starting three times per week vadadustat (TIW-V) who achieve a mean Hgb in a range of 9-11.5 g/dL during weeks 20-24 [Срок оценки: weeks 20-24]

Критерии участия

Критерии включения

  • Adult patients ≥18 years of age
  • Receiving outpatient in-center hemodialysis for ESKD at least TIW (prescribed)
  • Currently receiving EPO (active administration, not on HOLD)
  • Less than or equal to 0.75 g/d difference between last 2 Hgb values prior to Screening, with neither Hgb <9 g/dL
  • Average of last 2 Hgb between 9-11.4 g/dL (inclusive) prior to Screening
  • Central Screening Hgb 9-11.4 g/dL (inclusive)
  • Central Screening transferrin saturation greater than or equal to 20%
  • Central Screening serum ferritin greater than or equal to 100 ng/mL
  • Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure

Критерии исключения

  • Contraindication to receive vadadustat per United States Prescribing Information (USPI) including Screening liver function tests greater than 3x the upper limit of normal (ULN)
  • Electronic Medical Record (EMR)-documented history of cirrhosis or active, acute liver disease
  • EMR-documented history of currently active malignancy excluding non-melanomatous skin cancer and in-situ cervical cancer
  • Concomitant use of HIF-PHI or OAT1/OAT3 inhibitors (probenecid, rifampicin, gemfibrozil, or teriflunomide)
  • Unable to comply with study requirements or in the opinion of a healthcare provider or member of the central study team, not clinically stable to participate in the study
  • Documented unplanned absence from dialysis greater than or equal to 3 times in 30 days prior to Screening (excluding rescheduled dialysis treatments)
  • Pregnant at time of consent (per subject self-report)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07565701 · USRC-2026-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗