An Open-label, Randomized, Multi-centre, Multiple Dose Trial to Investigate the Efficacy and Safety of Subcutaneous Injections of RO0503821 at Different Dosing Intervals in Patients With Chronic Renal Anemia Who Are Not on Renal Replacement Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 65
- 主要终点
- The Change in Hemoglobin Over Time Between Baseline and End of Initial Treatment Based on Individual Regression Slopes
研究概览
简要总结
This study will evaluate the efficacy and safety of different subcutaneous starting doses and dosing frequencies of Mircera in anemic patients with chronic kidney disease not yet on dialysis. The anticipated time on study treatment is 3-12 months and the target sample size is <100 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;
- •not receiving renal replacement therapy.
排除标准
- •women who are pregnant, breastfeeding or using unreliable birth control methods;
- •administration of any investigational drug within 30 days preceding the screening visit and during the run-in period.
研究组 & 干预措施
Cohort 1 (RO0503821, 0.15 mcg/kg 1x/Week)
Eligible participants will be receiving RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) at a dose of 0.15 microgram per kilogram (mcg/kg) subcutaneously (SC) once every week to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period.
干预措施: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
Cohort 2 (RO0503821, 0.3 mcg/kg 1x/Week)
Eligible participants will be receiving RO0503821 at a dose of 0.3 mcg/kg SC once every week to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period.
干预措施: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
Cohort 3 (RO0503821, 0.6 mcg/kg 1x/Week)
Eligible participants will be receiving RO0503821 at a dose of 0.6 mcg/kg SC once every week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period.
干预措施: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
Cohort 4 (RO0503821, 0.3 mcg/kg 1x/2 Week)
Eligible participants will be receiving RO0503821 at a dose of 0.3 mcg/kg SC once every two week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period.
干预措施: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
Cohort 5 (RO0503821, 0.6 mcg/kg 1x/2Week)
Eligible participants will be receiving RO0503821 at a dose of 0.6 mcg/kg SC once every two week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period.
干预措施: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
Cohort 6 (RO0503821, 1.2 mcg/kg 1x/2 Week)
Eligible participants will be receiving RO0503821 at a dose of 1.2 mcg/kg SC once every two week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period.
干预措施: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
Cohort 7 (RO0503821, 0.45 mcg/kg 1x/3 Week)
Eligible participants will be receiving RO0503821 at a dose of 0.45 mcg/kg SC once every three week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period.
干预措施: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
Cohort 8 (RO0503821, 0.9 mcg/kg 1x/3Week)
Eligible participants will be receiving RO0503821 at a dose of 0.9 mcg/kg SC once every three week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period.
干预措施: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
Cohort 9 (RO0503821,1.8 mcg/kg 1x/3 Week)
Eligible participants will be receiving RO0503821 at a dose of 1.8 mcg/kg SC once every three week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period.
干预措施: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
结局指标
主要结局
The Change in Hemoglobin Over Time Between Baseline and End of Initial Treatment Based on Individual Regression Slopes
时间窗: From Baseline (Day -28 to Day 1) to EOIT (Week 19)
The primary efficacy variable was blood Hb level and its changes from Baseline (defined as the mean Hb of Screening assessment (SA) (Week -3), Weeks -2 and -1 of the Run-in period) over time during the core treatment period. For each participant, the primary efficacy parameter was the change in hemoglobin level over time based on regression slopes. All values until end-of-initial treatment (EOIT), defined as the last observed value before a dose change or blood transfusion, were included in the calculation of this endpoint. For participants without any dose adjustments, the EOIT value was identical to the value for Week 19.
次要结局
- Hematocrit Levels at End of Initial Treatment Under Constant Dosing Regimen(From Baseline (Day -28 to Day 1) to EOIT (Week 19))
- Heart Rate Over Time(Up to Week 125)
- Number of Participants With Any Serious Adverse Events and Any Adverse Events(Up to Week 125)
- Number of Participants With Marked Laboratory Abnormalities for Blood Chemistry and Electrolytes Over Time(Up to Week 125)
- Reticulocyte Count at End of Initial Treatment Under Constant Dosing Regimen(From Baseline (Day -28 to Day 1) to EOIT (Week 19))
- Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure(From Baseline (Day -28 to Day 1) to Week 125)