A Prospective Interventional Study Assessing the Clinical and Operational Effectiveness of Transitioning From Mircera to Daprodustat for the Treatment of Anemia in End Stage Kidney Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Change in hemoglobin from baseline to the effectiveness evaluation period
研究概览
简要总结
Investigator-initiated, interventional, prospective study to assess the clinical and operational effectiveness of daprodustat in adult patients receiving in center hemodialysis or peritoneal home dialysis who are transitioning from Mircera to daprodustat.
详细描述
Investigator-initiated, multicenter, prospective, interventional study to determine the clinical and operational effectiveness of transitioning from intravenous or subcutaneous Mircera to oral daily daprodustat as assessed by change in hemoglobin. This trial will be conducted at up to 40 United States Renal Care sites in the United States and will enroll approximately 200 patients (~150 in-center hemodialysis and ~50 home dialysis patients).
Participants who are prescribed daprodustat by their treating physician and have taken at least a single dose of daprodustat will be considered enrolled into the clinical trial. After the prescription of daprodustat by the treating physician, each subject will be followed prospectively for a treatment period of approximately 120 days.
Subjects taking daprodustat will not have any in-person study related visits and will follow their usual schedule with regard to standard of care. Standard of care laboratory assessments as ordered by the primary nephrologist will be utilized. Twice monthly hemoglobin collection and monitoring will be required as part of the standard of care laboratory assessments.
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
- •Adult patients ≥18 years old.
- •Diagnosis of end stage kidney disease and receiving maintenance dialysis (in-center hemodialysis or peritoneal dialysis) for ≥ 4 months.
- •Has received at least a single dose of Mircera within 45 days prior to prescription of Daprodustat by treating physician.
- •Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.
排除标准
- •A known allergy or intolerance to daprodustat or any of its constituents.
- •Uncontrolled hypertension.
- •Active malignancy as documented in electronic medical record.
- •Concomitant use of a strong CYP2C8 inhibitor such as gemfibrozil.
- •Severe hepatic impairment as documented in the electronic medical record.
研究组 & 干预措施
Commercial daprodustat
Prescription of oral daprodustat in accordance with the FDA approved package label.
干预措施: Daprodustat (Drug)
结局指标
主要结局
Change in hemoglobin from baseline to the effectiveness evaluation period
时间窗: 120 days
Change in hemoglobin from baseline (defined as the mean of all available hemoglobin values obtained in the 30 days prior to Day 1) to the effectiveness evaluation period (mean of all available hemoglobin values obtained in the 30 days prior to Day 120).
次要结局
- The number/proportion of subjects with a hemoglobin in target range of 10-11 g/dL from baseline to effectiveness evaluation period(120 days)
- Number of subjects retained on daprodustat therapy from Day 1 through Day 120(120 days)
- Average monthly (percent) compliance with daprodustat daily dosing, per subject report.(120 days)
- Number of hemoglobin excursions that are < 8.5 g/dL or ≥ 12 g/dL during the treatment period.(120 days)
- The number/proportion of subjects with a change in hemoglobin under 0.5 g/dL from baseline to effectiveness evaluation period(120 days)
- The time (in days) from initial and refill prescription to delivery to patient(120 days)
- Number of dose adjustments in daprodustat per patient during the treatment period(120 days)
- The number/proportion of subjects who receive a refill prescription with the correct prescribed dose with no gap (0 days) in drug supply from the previous prescription(120 days)