A Study to Evaluate Efficacy and Safety of QLG1218(Daprodustat) in Chinese Hemodialysis (HD)-Dependent Subjects With Anemia Associated With Chronic Kidney Disease (CKD)

Официальное название

A Randomized, Open Label, Active-controlled, Parallel-group, Multi-center Study to Evaluate Efficacy and Safety of QLG1218(Daprodustat) in Chinese Hemodialysis-dependent Subjects With Anemia Associated With Chronic Kidney Disease.

Обзор

This study is to evaluate the efficacy and safety of QLG1218(daprodustat) following a switch from erythropoiesis-stimulating agent (ESA) in Chinese HD subjects with renal anemia who are currently treated with ESA. The primary objective is to demonstrate non-inferiority of QLG1218 to darbepoetin alfa. This study is a randomized, open Label, active-controlled, parallel-group, multi-center Study. The total duration of the study will be approximately 32 weeks including screening and follow-up.

Вмешательства

• Препарат Daprodustat
  Subjects will receive oral daprodustat once daily for 28 weeks
• Препарат Darbepoetin alfa
  Subjects will receive IV darbepoetin alfa once weekly for 28 weeks

Первичные конечные точки

• Mean Hemoglobin (Hgb) During the Efficacy Evaluation Period [Срок оценки: Weeks 25 to 28]

Критерии участия

Критерии включения

• Female or male，age 18 to 75
• Weight 45 to 100 kg
• Receiving hemodialysis (including hemodiafiltration) consistently three times a week for at least 12 weeks prior to screening.
• Patients with pre-dialysis Hb levels measured after the maximum interdialytic interval at Scr Visit 1 and Scr Visit 2 (1 week after the start of observation) of ≥95 g/L and <120 g/L and a difference (in absolute value) between Scr Visit 1 and Scr Visit 2 of ≤15 g/L.
• TSAT >20% and ferritin >100 μg/L
• Use of one and the same ESA for 10 weeks prior to screening
• Darbepoetin alfa 10 to 60 μg per week, epoetin (including biosimilars) 1500 to 10000 international units (IU) per week.

Критерии исключения

• History of bone-marrow hypoplasia, pure red cell aplasia, pernicious anemia, thalassemia, sickle cell anemia, or myelodysplastic syndromes.
• History of malignancy.
• Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease OR clinically significant GI bleeding within 12 weeks prior to screening or during a period from screening to Day 1.
• Myocardial infarction, acute coronary syndrome, stroke, or transient ischemic attack: Diagnosed within 12 weeks prior to screening or during a period from screening to Day 1
• Chronic Class III or IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system.
• poorly controlled hypertension.
• Current unstable active liver or biliary disease.
• History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product.
• Use or planned use of any prescription or non-prescription drugs or dietary supplements that are prohibited during the study period.
• Use of an investigational agent within 30 days or five half lives of the investigational agent (whichever is longer)
• Use of daprodustat or other HIF-PHI within 4 weeks prior to screening, or any prior treatment with daprodustat for a treatment duration of > 4weeks.
• QTc >500 milliseconds (msec); or QTc >530 msec in subjects with bundle branch block.
• ALT or AST >2 upper limit of normal (ULN)，or bilirubin >1.5×ULN.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07300111 · QLG1218-301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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