A Randomized, Controlled Trial of Costs Associated With Anemia Therapy in Hemodialysis Patients Treated With Intravenous Darbepoetin Alfa Versus Epoetin Alfa
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- Cost of Erythropoiesis Stimulating Agent
研究概览
简要总结
The purpose of this study is to determine if there is a cost difference between darbepoetin alfa and epoetin alfa when used intravenously to treat anemia in hemodialysis patients.
详细描述
Eligible hemodialysis patients who are currently receiving an erythropoiesis stimulating agent (ESA) who enrol and sign consent will be randomized on a 1:1 basis to either remain on epoetin alfa or switch to darbepoetin alfa as their anemia therapy. Patients will be dosed with the assigned drug using a study algorithm to maintain their hemoglobin (Hb) level within the currently recommended range (100-120 g/L). There will be an initial "run in" period of a minimum of six weeks to ensure the patient's hemoglobin is stable within the target range. The trial itself will run for a subsequent twelve months (active phase). Every effort will be made to ensure that Hb stays within the target range during the study period. The primary outcome will be the total cost of each ESA therapy over the twelve month active phase. Data including Hgb, iron indices and dosing, and clinical events will be obtained from electronic sources and from the attending physicians and/or the clinical pharmacist.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥19 years
- •receiving in-center hemodialysis two or more times weekly
- •anemia requiring erythropoiesis stimulating (ESA) agent therapy OR a hemoglobin(Hb)<100g/L in the absence of other causes of anemia
- •if female, must be using an approved method of contraception or judged unable to become pregnant
- •able to give informed consent
排除标准
- •acute kidney injury likely to resolve
- •plans to change to peritoneal dialysis or home hemodialysis, or planned transplant from a living donor
- •expected lifespan of less than six months due to a medical condition other than chronic kidney disease
- •current hematologic condition that may cause anemia
- •use of medications known to cause anemia
- •use of any investigational drug or androgen within 90 days of screening
- •significant bleeding within 30 days of screening
- •red blood cell transfusion(s) within 30 days of screening
- •documented or suspected pure red cell aplasia (PRCA)
- •current iron deficiency
- •documented allergy or intolerance to intravenous sodium ferric gluconate
- •known or probable ESA resistance
- •uncontrolled hypertension
- •an intention to relocate to a different dialysis center in the near future
研究组 & 干预措施
Epoetin alfa
Patients who are enrolled and randomized to the Epoetin arm will remain on their current dose and frequency. After the first hemoglobin (Hb) measurement the study algorithm will be used to guide anemia management. The subjects in this arm will remain on epoetin for the required run-in phase followed by the 12 month active phase.
干预措施: Epoetin Alfa (Drug)
Darbepoetin alfa
Patients who are enrolled and randomized to the Darbepoetin arm will have their epoetin discontinued at the end of the week preceding entry into the study and will switch to darbepoetin on the date that they would normally be receiving their next dose of epoetin.
Switching patients to darbepoetin will be done using the conversion ratio of 200 units of epoetin to 1 μg of darbepoetin as used per week, rounded up or down to the nearest available pre-filled syringe dose available from the manufacturer.
After the first Hb measurement the study algorithm will be used to guide anemia management. The subjects in this arm will remain on darbepoetin for the required run-in phase followed by the 12 month active phase.
干预措施: Darbepoetin alfa (Drug)
结局指标
主要结局
Cost of Erythropoiesis Stimulating Agent
时间窗: 12 months
total cost over 12 months in Canadian dollars
次要结局
- Iron Cost(12 months)
- Ferritin(12 months)
- Hemoglobin(12 months)
- Transferrin Saturation (TSAT)(12 months)
- Iron Dose(12 months)
研究者
Andrea L Woodland
Clinical Pharmacist
Eastern Health, Canada