Different Doses of Roxadustat Treatment on Hemoglobin Target-met in Peritoneal Dialysis Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The ratio of hemoglobin achieving the target (115g/L)
研究概览
简要总结
A multi-center, randomized, controlled study to evaluate the effect of different doses of roxadustate on hemoglobin target-met in peritoneal dialysis patients
详细描述
Roxadustat is an orally hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) to promote erythropoiesis on patients with chronic kidney disease. Two phase 3 clinical trials have verified the efficacy and safety of roxadustate as therapy for anemia in patients with CKD and undergoing dialysis. A high increasing rate of Hb or Hb overshooting triggered by roxadustat need dosing reduction or even drug withdrawal, possibly leading to a large Hb variation and adverse subsequences. Therefore, we were of interest to investigate whether a lower starting dose of roxadustat could achieve comparable Hb target at week 12 while lowering the risk for Hb over 130g/L through a prospective peritoneal dialysis (PD) cohort. Peritoneal dialysis patients diagnosed with renal anemia will be divided into standard roxadustat dosage group and lower roxadustat dosage group. After 12 weeks, we will compare the target-met, overshooting and variation ratio of hemoglobin between these two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients diagnosed with Chronic kidney disease stage 5
- •Maintenance on PD for more than three months.
- •Weight between 45Kg and 110Kg
- •Renal anemia, and hemoglobin between 90g/L and 120g/L
- •Stop taking erythropoietin for enough time （erythropoietin treatment discontinuation for ≥3 days if using erythropoietin of 3000U single strength, or ≥7 days if using erythropoietin of 10000U single strength） or free of erythropoietin use
- •Signed the informed consent.
- •Willing to follow the study procedure
排除标准
- •Hematologic malignancy or aplastic anemia.
- •Blood loss or hemolysis.
- •Taking roxadustat, or Allergy or intolerance to roxadustat
- •Severe liver injury or active hepatitis.
- •Pregnancy or breastfeeding
- •Cancer, receiving radiotherapy and chemotherapy within 6 months.
- •Refractory hypertension
研究组 & 干预措施
standard roxadustat dosage group
Peritoneal dialysis patients diagnosed with renal anemia will receive standard dosage of roxadustat according to weight.
干预措施: Roxadustat (Drug)
lower roxadustat dosage group
Peritoneal dialysis patients diagnosed with renal anemia will receive lower dosage of roxadustat according to weight.
干预措施: Roxadustat (Drug)
结局指标
主要结局
The ratio of hemoglobin achieving the target (115g/L)
时间窗: 12 weeks
The ratio of hemoglobin achieving the target (115g/L) on week 8 and week 12.
次要结局
- The ratio of hemoglobin over-shooting(12 weeks)
- The variation ratio of hemoglobin(12 weeks)
研究者
Dong Jie
Clinical Professor
Peking University First Hospital