NCT05082571撤回3 期
A Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Once Daily Oral Vadadustat for the Treatment of Pediatric Subjects With Anemia of Chronic Kidney Disease After Conversion From an Erythropoiesis-stimulating Agent
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Mean Change in Hemoglobin (Hb) Values Between Baseline and the Primary Evaluation Period (Average Hb From Weeks 21 to 28)
研究概览
简要总结
This study will assess the safety and efficacy of once daily dosing of vadadustat for the treatment of pediatric participants with anemia of Chronic Kidney Disease (CKD) after conversion from an Erythropoiesis Stimulating Agent (ESA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Months 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of anemia of chronic kidney disease (CKD)
- •Diagnosis of non-dialysis-dependent (NDD) CKD with an estimated glomerular filtration rate of greater than (>) 10 and less than (<) 60 milliliters/minute/1.73 meters^2 (mL/min/1.73 m^2) or diagnosis of dialysis dependent (DD) CKD
- •Mean hemoglobin (Hb) between 9.0 and 12.0 grams/deciliters (g/dL) (inclusive)
- •Transferrin Saturation ≥ 20%
排除标准
- •Anemia due to a cause other than CKD
- •Active bleeding or recent clinically significant blood loss
- •History of sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia
- •Red Blood Cells transfusion within 4 weeks
- •Serum albumin level less than 2.5 g/dL
- •Uncontrolled hypertension
- •Active malignancy or treatment for malignancy within the past 2 years prior to Screening
- •Evidence of iron overload or diagnosis of hemochromatosis
- •Known hypersensitivity to vadadustat or any excipients in vadadustat tablet
研究组 & 干预措施
Vadadustat
Experimental
Cohort 1: participants with ≥12 years to <17 years; Cohort 2: participants with ≥6 years to <12 years; Cohort 3(a): participants with ≥2 years to <6 years; and Cohort 3(b): participants with ≥4 months to <2 years
干预措施: vadadustat (Drug)
结局指标
主要结局
Mean Change in Hemoglobin (Hb) Values Between Baseline and the Primary Evaluation Period (Average Hb From Weeks 21 to 28)
时间窗: Baseline; Weeks 21 to 28
次要结局
- Number of Participants With Treatment-emergent Adverse Events and who Discontinued From the Study due to Adverse Events(Up to Week 56)
- Change From Baseline in Reticulocyte Count(Pre-dose and post-dose at intermediate time points up to 28 weeks)
- Time to Achieve Hb Levels of ≥10.0 grams/deciliters (g/dL)(Up to Week 52)
- Change From Baseline in Serum Erythropoietin (EPO)(Pre-dose and post-dose at intermediate time points up to 28 weeks)
- Number of Participants With Mean Hb Values Within the Target Range During the Primary Evaluation Period(From Week 21 to Week 28)
- Maximum Observed Plasma Concentration (Cmax) of Vadadustat and its Metabolites(Pre-dose and post-dose at intermediate time points up to 28 weeks)
- Time to Reach Cmax (Tmax) of Vadadustat and its Metabolites(Pre-dose and post-dose at intermediate time points up to 28 weeks)
- Number of Participants With Mean Hb Values Within the Target Range During the Extension Period(From Week 29 to Week 52)
- Area Under the Plasma Concentration-Time Curve From 0 to Last Quantifiable Concentration (AUC 0-t) of Vadadustat and its Metabolites(Pre-dose and post-dose at intermediate time points up to 28 weeks)
- Terminal Elimination Half-Life (t1/2) of Vadadustat and its Metabolites(Pre-dose and post-dose at intermediate time points up to 28 weeks)
- Change From Baseline in Hb levels(Pre-dose and post-dose at intermediate time points up to 28 weeks)
研究者
研究点 (1)
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