Phase 3b Multicenter, Open-Label Single Arm Study of Roxadustat: Either as Conversion From an Erythropoiesis Stimulating Agent (ESA), or as Initial Anemia Treatment in Hemodialysis (HD) Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- FibroGen
- 入组人数
- 283
- 试验地点
- 4
- 主要终点
- Percentage of Participants With Mean Hb Value ≥10 g/dL
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of roxadustat dosing regimens among hemodialysis participants converted from erythropoiesis stimulating agent (ESA) therapy or who are ESA-naïve.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving chronic dialysis for end stage renal disease (ESRD)
- •Vascular access must be a functioning native arteriovenous fistula or graft with adequate flow in the opinion of the investigator, or permanent tunnelled catheter
- •Screening Hb criteria: Participants converting from an ESA: between 9.0 to 12.0 grams (g)/deciliter (dL); Participants initiating anemia treatment: < 10.0 g/dL
- •Ferritin ≥ 50 nanograms (ng)/mililiter (mL), Transferrin saturation (TSAT) ≥ 10% at screening
- •Participant's alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are ≤ 3 x upper limit of normal (ULN), and total bilirubin (TBL) is ≤ 1.5 x ULN at screening and prior to initiating roxadustat treatment.
- •Body weight between 45.0 to 160.0 kg
排除标准
- •Red blood cell (RBC) transfusion within 4 weeks prior to enrollment
- •Known history of myelodysplastic syndrome or multiple myeloma
- •Known hereditary hematologic disease or other known causes for anemia other than chronic kidney disease (CKD)
- •Known chronic inflammatory disease that is determined by the investigator to be the primary cause of anemia
- •Active or chronic gastrointestinal bleeding
- •Treated with iron-chelating agents within 4 weeks prior to enrollment
- •History of New York Heart Association (NYHA) Class III or IV congestive heart failure
- •History of myocardial infarction, acute coronary syndrome, stroke, seizure, or a thrombotic/thromboembolic event (excluding vascular dialysis access stenosis/thrombosis) within 12 weeks prior to enrollment
- •Uncontrolled hypertension, in the opinion of the Investigator
- •Participant has a diagnosis or suspicion (for example, complex kidney cyst of Bosniak Category II or higher) of renal cell carcinoma (Principal Investigator's discretion)
- •History of malignancy, except for cancers determined to be cured or in remission for ≥ 2 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps
研究组 & 干预措施
Roxadustat
Participants will receive roxadustat as an oral tablet, 3 times per week (TIW) for up to a maximum of 24 weeks. If a participant require roxadustat <60 milligrams (mg)/week to maintain hemoglobin (Hb) levels, the dose frequency will be reduced in a stepwise manner, for example, to twice weekly (BIW), and then once weekly (QW). For participants converted from an ESA, the initial roxadustat dose will be based on the average prescribed ESA dose in the last 4 weeks (for epoetin alfa and darbepoetin alfa) or 8 weeks (for methoxy polyethylene glycol-epoetin beta [Mircera®]). For participants with <6 weeks of prior ESA use, the initial roxadustat dose will be based on a 2-tiered, weight-based dosing scheme. Dose adjustment evaluations will be made every 4 weeks and doses will be titrated based on Hb level and rate of Hb change. The prescribed dose will not exceed the maximum allowable dose of 3.0 mg/kilogram (kg)/dose or 400 mg per dose, whichever is lower.
干预措施: Roxadustat (Drug)
结局指标
主要结局
Percentage of Participants With Mean Hb Value ≥10 g/dL
时间窗: Week 16 through Week 24
Percentage of participants with mean Hb value ≥10 g/dL, averaged from Week 16 through Week 24 has been reported. Baseline Hb was defined as the mean of available central laboratory Hb values prior to first dose of study medication including the predose Hb value collected on Day 1. 95% confidence interval (CI) was calculated based on the normal approximation to the binomial distribution.
Mean Hb Change From Baseline to Average Hb From Weeks 16-24
时间窗: Baseline, Weeks 16-24
Baseline Hb was defined as the mean of available central laboratory Hb values prior to first dose of study medication including the predose Hb value collected on Day 1. Missing data was imputed using Monte Carlo Markov Chain (MCMC) imputation model.
次要结局
未报告次要终点