An Open-label, Randomized, Multicenter, Parallel-group Study to Demonstrate Correction of Anemia Using Once Every 4 Weeks Subcutaneous Injections of RO0503821 in Patients With Chronic Kidney Disease Who Are Not on Dialysis
概览
- 阶段
- 3 期
- 干预措施
- Methoxy polyethylene glycol-epoetin beta
- 疾病 / 适应症
- Renal Anemia, Chronic
- 发起方
- Hoffmann-La Roche
- 入组人数
- 307
- 主要终点
- Percentage of Participants With Hemoglobin (Hb) Response
- 状态
- 已完成
- 最后更新
- 9年前
概览
简要总结
This study will compare the efficacy and safety of subcutaneous Mircera and subcutaneous darbepoetin in the treatment of renal anemia in participants with chronic kidney disease who are not on dialysis and not receiving erythropoiesis-stimulating agents (ESA). Participants will be randomized to receive either Mircera once every 4 weeks, at a starting dose of 1.2 micrograms/kilogram (mcg/kg), or darbepoetin alfa once weekly, at a starting dose of 0.45 mcg/kg (or once every two weeks, 0.75 mcg/kg). The anticipated time on study treatment is 3-12 months.
研究者
入排标准
入选标准
- •Participants with chronic kidney disease (CKD) stage 3 (creatinine clearance \[CrCl\]/ glomerular filtration rate \[GFR\] 30 to 59 milliliter per minutes per 1.73 meter square \[mL/min/1.73m\^2\]) or Stage 4 (CrCl/GFR 15-29 mL/min/1.73m\^2) who did not require dialysis. CrCl/GFR was estimated with the Cockcroft-Gault equation or the abbreviated Modification of Diet in Renal Disease (MDRD) equation
- •Anemia defined as baseline Hb concentration less than (\<) 10.5 gram per deciliter (g/dL)
排除标准
- •Previous therapy with any ESA within 12 weeks prior to screening
- •Renal allograft in place
- •Immunosuppressive therapy in the 12 weeks prior to screening
- •Overt gastrointestinal bleeding and red blood cells (RBC) transfusions within 8 weeks before screening
研究组 & 干预措施
Mircera
Participants will receive Mircera (Methoxy polyethylene glycol-epoetin beta), administered subcutaneously (SC) at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
干预措施: Methoxy polyethylene glycol-epoetin beta
Darbepoetin Alfa
Participants will receive darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
干预措施: Darbepoetin alfa
结局指标
主要结局
Percentage of Participants With Hemoglobin (Hb) Response
时间窗: Baseline up to Week 28
Hb response was an observed increase in Hb greater than or equal to (\>=) 1.0 gram per deciliter (g/dL) from baseline and an Hb concentration \>= 10.0 g/dL before the end of the study without red blood cells (RBC) transfusion before response.
Change in Hemoglobin (Hb) Concentration Between Baseline and Evaluation Period
时间窗: Baseline (measurements at Week -2, Week -1 and Day 1) and Evaluation Period (Week 22, Week 24, Week 26, Week 28)
A time adjusted average baseline Hb concentration was calculated using the trapezoid rule from all available Hb measurements taken during the baseline period. The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the 2 month evaluation period (Week 21 to 28). The change in Hb concentration between the baseline and evaluation period was calculated by subtracting the baseline Hb from the evaluation period Hb. All blood samples for Hb measurements were taken prior to study drug administration.
次要结局
- Percentage of Participants With Red Blood Cell (RBC) Transfusions(Baseline up to Week 28)
- Percentage of Participants Who Had at Least 1 Hemoglobin Value Exceeding 12.0 g/dL(Baseline to Week 8)
- Percentage of Participants With Stable Hemoglobin Response(Baseline to Week 28)
- Hemoglobin (Hb) Concentration Over the Time(Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and final visit (Week 29))
- Time to Hemoglobin Response(Baseline up to Week 28)
- Percentage of Participants Who Required Dose Adjustments to Achieve a Stabilized Response(Baseline to Week 28)