Open-Label Extension Study to Evaluate the Efficacy and Safety of FG-4592 for the Long-Term Maintenance Treatment of Anemia in Dialysis and Non-Dialysis Patients With Chronic Kidney Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- FibroGen
- 入组人数
- 15
- 试验地点
- 5
- 主要终点
- Change From Baseline in Hb Over Time
研究概览
简要总结
The purpose of this open-label extension study is to evaluate long-term efficacy and safety of roxadustat in maintaining hemoglobin (Hb) in participants with dialysis and non-dialysis chronic kidney disease (CKD) who have completed the Treatment Period of a roxadustat FibroGen-sponsored anemia study.
详细描述
This is an open-label, long-term maintenance study of roxadustat anemia therapy in participants with dialysis and non-dialysis CKD who have completed the Treatment Period of a roxadustat FibroGen-sponsored anemia study. Participants assigned to roxadustat in the previous study will continue to receive the same roxadustat dose and dosing frequency, unless a dose adjustment is required.
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
- •Minimum age 18 years
- •Completed the Treatment Period of an ongoing roxadustat FibroGen-sponsored anemia study in the United States.
- •Exclusion Criteria
- •Participants assigned to epoetin alfa in a previous ongoing roxadustat anemia study
- •Pregnant or breastfeeding females
- •Females of childbearing potential, unless using adequate contraception; male participants with sexual partners of childbearing potential who are not on birth control unless the male participant agrees to use adequate contraception
- •Participants who received roxadustat in a previous study that did not demonstrate adequate hemoglobin response per the investigator's clinical judgment
- •Any medical condition that in the opinion of the investigator may pose a safety risk to a participant in this study or which may interfere with study participation
排除标准
- 未提供
研究组 & 干预措施
Roxadustat
Participants previously randomized to roxadustat will receive roxadustat at the same dose and frequency assigned at the last dose in the previous FibroGen study. Dose adjustments will be implemented (up to a maximum roxadustat dose of 3.0 mg/kg or 400 mg, whichever is lower) every 4 weeks to maintain Hb levels at 10.0-12 grams (g)/deciliter (dL). However, if a participant, at any dose, experiences an event of excessive hematopoiesis then the participant's dose will be immediately reduced, or an event of rapidly declining Hb then the participant's dose will be immediately increased. Participants will be permitted to receive roxadustat for up to 8 years.
干预措施: Roxadustat (Drug)
结局指标
主要结局
Change From Baseline in Hb Over Time
时间窗: Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 252, 264, 288, 312, 336, 360, and 384
Hb baseline was defined as the mean of the central laboratory Hb value from the baseline visit at Day 1 (prior to receiving the first dose of study drug in this study), plus any other central lab Hb values within 15 days prior to Day 1 regardless of fasting. The specific duration over which the participants were assessed was identified as "over time" for the endpoint in the study protocol. Therefore, to be consistent with the endpoint in the study protocol, an individual timepoint was not identified for this primary outcome measure.
次要结局
- Number of Participants With Hb ≥10 g/dL(Baseline up to Week 384)
- Number of Participants Receiving Rescue Therapy (Composite of Blood Transfusions, Intravenous [IV] Iron, Erythropoiesis-Stimulating Agent [ESA])(Baseline up to Week 385)
- Mean Weekly Dose of Study Drug Over Time(Baseline up to Week 384)
- Number of Participants With Dose Adjustments up to Week 52(Baseline up to Week 52)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs(Baseline up to Week 385)