An Open-label, Multicenter, Randomized Study to Determine Dose Conversion Factors at Different Frequencies of Administration After Switching From Maintenance Treatment With Subcutaneous Epoetin Alfa or Beta to Maintenance Treatment With Subcutaneous RO0503821 in Dialysis Patients With Chronic Renal Anemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 137
- 主要终点
- Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen
研究概览
简要总结
This study will determine the appropriate dose and frequency of administration of sc Mircera maintenance therapy in dialysis patients with chronic renal anemia who were previously receiving sc epoetin alfa or beta. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
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
- 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 of age;
- •chronic renal anemia;
- •on dialysis (hemodialysis or peritoneal dialysis) therapy for at least 3 months;
- •receiving sc epoetin alfa or beta for at least 3 months prior to the run-in period.
排除标准
- •women who are pregnant, breastfeeding or using unreliable birth control methods;
- •use of any investigational drug within 30 days preceding the run-in phase, or during the run-in or study treatment period.
研究组 & 干预措施
Cohort A (0.4/150, 1x/ Week)
Eligible participant will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) SC using a dose conversion factor of 0.4/150 microgram (mcg)/ kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
干预措施: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
Cohort B (0.4/150, 1x/ 3 Weeks)
Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
干预措施: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
Cohort C (0.4/150, 1x/ 4 Weeks)
Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
干预措施: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
Cohort D (0.8/150, 1x/ Week)
Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
干预措施: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
Cohort E (0.8/150, 1x/ 3 Weeks)
Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
干预措施: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
Cohort F (0.8/150, 1x/ 4 Weeks)
Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
干预措施: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
Cohort G (1.2/150, 1x/ Week)
Eligible participant will be administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
干预措施: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
Cohort H (1.2/150, 1x/ 3 Weeks)
Eligible participant will be administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
干预措施: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
Cohort I (1.2/150, 1x/ 4 Weeks)
Eligible participant will be administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
干预措施: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
结局指标
主要结局
Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen
时间窗: From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21)
Median change from Baseline in hemoglobin (Hb) levels to end of initial treatment (EOIT) under constant dosing regimen was reported. For ease of interpretation, all individual slope values were multiplied by 42 to give an estimate of change in Hb values over six weeks. Baseline (Day -28 to Day 1) Hb values was calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and -1). For all participants, an EOIT value was calculated as the last observed Hb value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 (or Week 21) value.
次要结局
- Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen(From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21))
- Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis(From Baseline (Day -28 to Day 1) to Week 126)
- Mean Change in Pulse Rate(Up to Week 126)
- Number of Participants With Marked Laboratory Abnormalities(Up to Week 126)
- Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths(Up to Week 126)