A Prospective, Randomized, Open-Label, Multi-Center Study to Evaluate the Efficacy and Safety of Multiple Roxadustat Dosing Regimens for the Treatment of Anemia in Dialysis Subjects With Chronic Kidney Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- FibroGen
- 入组人数
- 318
- 试验地点
- 1
- 主要终点
- Part 1 (ESA Naïve): Percentage of Participants who Achieved Hb ≥110 g/L in the First 20 Weeks
研究概览
简要总结
This is a randomized, open-label, multi-center study in dialysis chronic kidney disease (CKD) participants to evaluate the efficacy and relative safety of different dosing regimens of roxadustat over a 36-week treatment period.
There are 3 study periods:
- Screening Period (up to 4 weeks)
- Treatment Period (36 weeks)
Part 1: Correction/Conversion Period (Weeks 1-20)
Part 2: Hemoglobin (Hb) Maintenance Period (Weeks 21-36)
- Follow-up Period (4 weeks)
详细描述
Approximately 102 erythropoiesis stimulating agents (ESA)-naïve participants and 204 ESA-treated participants will be enrolled and randomized respectively in a 1:1 ratio to receive roxadustat at one of 2 starting doses as below:
- Low weight-based dosing: 70 milligrams (mg) 3 times a week (TIW) for body weight <60 kilograms (kg) or 100 mg TIW for body weight ≥60 kg
- Standard weight-based dosing: 100 mg TIW for body weight <60 kg or 120 mg TIW for body weight ≥60 kg
After 20 weeks of treatment, all eligible participants whose last 2 Hb levels ≥105 grams (g)/liter (L) and change in Hb over the most recent 4 weeks is > - 10 g/L will switch to receive roxadustat for another 16 weeks to evaluate the efficacy and safety of new dosing regimens.
At the end of Week 36, all participants will discontinue roxadustat and enter a 4-week Follow-up Period.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CKD with end-stage renal disease (ESRD) on either hemodialysis (HD) or peritoneal dialysis (PD)
排除标准
- •Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab).
- •Myocardial infarction, acute coronary syndrome, stroke, seizure, or a thromboembolic event (for example, deep venous thrombosis or pulmonary embolism) within 26 weeks prior to Day
- •History of malignancy, myelodysplastic syndrome, and multiple myeloma.
- •Chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis (for example, systemic lupus erythematosis [SLE], rheumatoid arthritis, celiac disease).
- •Clinically significant gastrointestinal bleeding.
- •Women of childbearing potential and men with sexual partners of child bearing potential who are not using adequate contraception.
研究组 & 干预措施
Part 1: ESA-Naïve Participants - Low Weight Based Dosing
ESA-naïve participants will receive roxadustat 70 mg TIW for body weight 45 to <60 kg or 100 mg TIW for body weight ≥60 kg.
干预措施: Roxadustat (Drug)
Part 1: ESA-Naïve Participants - Standard Weight Based Dosing
ESA naïve participants will receive roxadustat 100 mg TIW for body weight 45 to <60 kg or 120 mg TIW for body weight ≥60 kg.
干预措施: Roxadustat (Drug)
Part 1: ESA-Treated Participants - Low Weight Based Dosing
ESA-treated participants will receive roxadustat 70 mg TIW for body weight 45 to <60 kg or 100 mg TIW for body weight ≥60 kg.
干预措施: Roxadustat (Drug)
Part 1: ESA-Treated Participants - Standard Weight Based Dosing
ESA treated participants will receive roxadustat 100 mg TIW for body weight 45 to <60 kg or 120 mg TIW for body weight ≥60 kg.
干预措施: Roxadustat (Drug)
Part 2: Roxadustat QW
Participants will receive roxadustat once a week (QW). Roxadustat dose will be 2-dose step increase from originally planned week 21 TIW per dose amount.
干预措施: Roxadustat (Drug)
Part 2: Roxadustat BIW
Participants will receive roxadustat twice a week (BIW). Roxadustat dose will be 1-dose step increase from originally planned week 21 TIW per dose amount.
干预措施: Roxadustat (Drug)
Part 2: Roxadustat TIW
Participants will receive roxadustat TIW. Roxadustat dose will continue per dose adjustment guideline.
干预措施: Roxadustat (Drug)
结局指标
主要结局
Part 1 (ESA Naïve): Percentage of Participants who Achieved Hb ≥110 g/L in the First 20 Weeks
时间窗: Weeks 1 to 20
Part 1 (ESA Treated): Percentage of Participants who Achieved Mean Hb ≥100 g/L Averaged Over Weeks 17 to 21 Visits
时间窗: Weeks 17 to 21
Part 2: Mean Hb Value Averaged Over Weeks 33 to 37 Visits
时间窗: Weeks 33 to 37
次要结局
- Part 1: Mean Change in Hb Level From Baseline to Average Over Weeks 17 to 21 Visits(Baseline, Weeks 17 to 21)
- Part 1 (ESA-Naïve): Percentage of Participants With Mean Hb (Averaged Weeks 17 to 21 Visits) ≥100 g/L(Weeks 17 to 21)
- Part 2: Percentage of Participants With Mean Hb (Averaged Weeks 33 to 37 Visits) ≥100 g/L(Weeks 33 to 37)