Specified Drug Use-Results Survey of EVRENZO® Tablets: Non-interventional, Prospective Drug Use-results Survey in the Realworld Use of EVRENZO® Tablets (Roxadustat) in Patients With Renal Anemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,104
- 试验地点
- 47
- 主要终点
- Proportion of participants with malignant tumors
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy, including the incidence of thromboembolism, in renal anemia patients treated with roxadustat (EVRENZO® Tablets) in actual clinical settings.
详细描述
This is a post-marketing long-term specified drug use-result survey study required for products in Japan. In the survey, patient registration and data collection will be conducted using post-marketing survey data collection system, PostMaNet via the Internet.
Patients who are eligible for the survey will be registered within 14 days after the start of treatment with roxadustat (including the start day of treatment). For all registered patients (including discontinuations/dropouts), the investigator will enter the necessary information in the case report form (CRF) and send it immediately after the end of the specified observation period for each patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Renal anemia patients who are naïve to roxadustat.
排除标准
- •Not applicable
研究组 & 干预措施
Roxadustat
Participants will receive oral dose of roxadustat.
干预措施: Roxadustat (Drug)
结局指标
主要结局
Proportion of participants with malignant tumors
时间窗: Up to Week 104
Number of participants with malignant tumors compared to number of participants evaluated.
Achievement rate for target Hb level
时间窗: Up to Week 104
Percent of participants who achieved target Hb level (10.0 to 12.0 g/dL).
Mean Hb levels at 4 weeks after switching to roxadustat
时间窗: At Week 4
Hb levels at 4 weeks after switching from ESA to roxadustat.
Proportion of participants with Adverse Drug Reactions (ADR)
时间窗: Up to Week 104
An AE is defined as any unwanted medical occurrence after drug administration and which does not necessarily have a causal relationship with the treatment. ADR is AEs whose relationship to the study drugs could not be ruled out is considered adverse drug reaction. AEs that fall under either "Probable" or "Possible" or "Unassessable" should be defined as "AEs whose relationship to the study drugs could not be ruled out.
Proportion of Participants With Serious Infection
时间窗: Up to week 104
Number of participants with serious infection will be reported.
Proportion of participants with serious ADR
时间窗: Up to Week 104
ADR is considered "serious" if, in the view of the investigator, the event: results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly or birth defect, requires hospitalization or prolongation to hospitalization, or other medically important event.
Proportion of participants with thromboembolism
时间窗: Up to Week 104
Number of participants with thromboembolism compared to number of participants evaluated.
Proportion of participants with retinal hemorrhage
时间窗: Up to Week 104
Number of participants with retinal hemorrhage compared to number of participants evaluated.
Proportion of Participants With Central Hypothyroidsm
时间窗: Up to Week 104
Number of participants with central hypothyroidsm compared to number of participants evaluated.
Proportion of Participants With Renal Function Disorder
时间窗: Up to week 104
Number of participants with renal function disorder reported as adverse drug reaction in participants with autosomal dominant polycystic kidney disease (ADPKD) will be reported.
Proportion of participants with ADR with high doses of roxadustat
时间窗: Up to Week 104
Number of participants with ADR with high doses of roxadustat compared to number of participants evaluated.
Proportion of participants with hypertension
时间窗: Up to Week 104
Number of participants with hypertension compared to number of participants evaluated.
Proportion of Participants With Seizures
时间窗: Up to week 104
Number of participants with seizures will be reported.
Change from baseline in Hemoglobin (Hb) levels
时间窗: Up to Week 104
Hb will be recorded from blood samples collected.
Proportion of participants with ADR within 4 weeks after switching to roxadustat
时间窗: Up to Week 4
Number of participants with ADR within 4 weeks after switching from erythropoiesis stimulating agent (ESA) to roxadustat compared to number of participants evaluated.
Mean value of Hb levels over time
时间窗: Up to Week 104
Hb will be measured throughout the period.
Proportion of participants with hepatic function disorder
时间窗: Up to Week 104
Number of participants with hepatic function disorder compared to number of participants evaluated.
Proportion of participants with myopathy events
时间窗: Up to Week 104
Number of participants with myopathy events related to the concomitant use of hydroxymethylglutaryl-CoA (HMG-CoA) reductase inhibitors compared to number of participants evaluated.
次要结局
未报告次要终点