NCT07722988尚未招募3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) in Participants With High Red Blood Cell Transfusion Burden
Kyntra Bio0 个研究点目标入组 201 人开始时间: 2027年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 201
- 主要终点
- Percentage of Participants With Red Blood Cell-transfusion Independence (RBC-TI) Over Any Consecutive 56-day Period
研究概览
简要总结
The study is designed to determine the efficacy and safety of roxadustat for the treatment of anemia due to very low, low, or intermediate risk MDS in participants with high transfusion burden (HTB).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Diagnosis of MDS according to World Health Organization (WHO) criteria confirmed by bone marrow aspirate and biopsy within 12 weeks before randomization.
- •Revised International Prognostic Scoring System (IPSS-R) very low, low, or intermediate risk MDS
- •HTB: Participants requiring ≥ 4 units of packed red blood cell (pRBC) in two consecutive 8-week periods prior to randomization
- •Refractory to, intolerant to, or ineligible for prior erythropoiesis-stimulating agents (ESAs).
- •Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
排除标准
- •Pregnant or breastfeeding females
- •Participant has any significant medical illness or is considered vulnerable by local regulations
- •Prior allogeneic or autologous stem cell transplant
- •Major surgery within 8 weeks prior to randomization.
- •Note: Other protocol-defined inclusion and exclusion criteria may apply.
结局指标
主要结局
Percentage of Participants With Red Blood Cell-transfusion Independence (RBC-TI) Over Any Consecutive 56-day Period
时间窗: Week 1 through Week 24
次要结局
- Percentage of Participants With RBC-TI Over Any Consecutive 84-day Period(Week 1 through Week 48 or end of treatment (EOT; up to 5 years))
- Percentage of Participants With RBC-TI Over Any Consecutive 112-day Period(Week 1 through Week 48 or EOT (up to 5 years))
- Percentage of Participants With ≥50% Reduction in Rate of Total Red Blood Cell (RBC) Units Transfused During a 16-week Period(Week 1 through Week 48 or EOT (up to 5 years))
- Percentage of Participants With RBC-TI Over Any Consecutive 168-day Period(Week 1 through Week 48 or EOT (up to 5 years))
研究者
相似试验
已完成
3 期
A Study to Evaluate the Efficacy and Safety of Roxadustat for the Treatment of Anemia in Participants Receiving Chemotherapy Treatment for Non-Myeloid MalignanciesChemotherapy Induced AnemiaNCT05301517FibroGen159
已完成
3 期
Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease (CKD), Not on DialysisAnemiaNCT02174627AstraZeneca2,781
已完成
不适用
Comparison Between Darbapoeitin Alpha and Roxadustat in CKD-related AnemiaCKD AnemiaCKD Anemia in Stable Dialysis PatientsNCT07517744Ain Shams University35
Unknown
不适用
罗沙司他改善炎性贫血的临床研究ChiCTR2600118233自选课题（自筹）43
招募中
3 期
A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking RuxolitinibMyelofibrosisAnemiaNCT07623161Takeda324