A Two-arm, Randomized, Open-label, Multicenter Study of Safety and Efficacy of Monthly Injections of RO0503821 Versus Epoetin Alfa in Peritoneal Dialysis Patients Who Self Inject or Receive In-center Injections.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 80
- 主要终点
- Mean Change From Baseline in Hb Concentration to Average Over the Evaluation Period
研究概览
简要总结
This 2 arm study will compare the efficacy of monthly Mircera and epoetin alfa in peritoneal dialysis patients who self-inject at home or receive in-centre injections. The safety of subcutaneous (sc) Mircera and injection site reactions and patient satisfaction will also be assessed. Eligible patients will be randomized either to receive monthly sc injections of Mircera (and will be switched from sc epoetin alfa) at a starting dose of 120-360 micrograms, or to remain on standard of care sc epoetin alfa. Dose adjustments will be permitted to reach/maintain a hemoglobin level of 10-12g/dL. The anticipated time on study treatment is 3-12 months, and the target sample size is 380 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 kidney disease stage V;
- •on peritoneal dialysis for 3 months prior to screening;
- •on epoetin alfa sc >=3 months prior to screening.
排除标准
- •patients expecting to change dialysis modality over course of study;
- •patients hospitalized during previous 3 months for any clinically significant condition;
- •active malignancy;
- •bleeding episode necessitating transfusion, or overt gastrointestinal bleeding within 3 months prior to screening;
- •transfusion of red blood cells within 3 months prior to screening.
研究组 & 干预措施
RO0503821
Eligible participants will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) will be based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses will be adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization will continue to do so.
干预措施: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
Epoetin Alfa
Eligible participants will be administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and will be followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization will continue to do so.
干预措施: Epoetin alfa (Drug)
结局指标
主要结局
Mean Change From Baseline in Hb Concentration to Average Over the Evaluation Period
时间窗: From Baseline (D 0) to 9 months
Mean change in Hb concentration from Baseline (Day \[D\] 0) to average during the evaluation period (Month 7 to 9) is reported.
次要结局
- Mean Change From Baseline in Ferritin(From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8)
- Mean Change From Baseline in Transferrin Saturation(From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8)
- Mean Change From Baseline in Serum Transferrin(From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8)
- Mean Change From Baseline in Pulse Rate(From Baseline (D 0) to D1 and D15 of M7, M8)
- Mean Change From Baseline in Weight(From Baseline (D 0) to D1 and D15 of M7, M8)
- Number of Participants With Anti-RO0503821 Antibody in Human Serum(Up to Month 9)
- Percentage of Participants With Safety-Related Hb Measures(Up to Month 9)
- Number of Participants With Marked Laboratory Abnormalities(Up to Month 9)
- Mean Change From Baseline in Total Iron-binding Capacity(From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8)
- Mean Change From Baseline in Iron(From Baseline (D 0) to Month (M) 2, M3, M4, M5, M6, M7, M8)
- Mean Change From Baseline in Temperature(From Baseline (D 0) to D1 and D15 of M7, M8)
- Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure(From Baseline (D 0) to D1 and D15 of M7, M8)
- Number of Participants With Anti-erythropoietin Antibody in Human Serum(Up to Month 9)
- Number of Participants With Any AEs, Any Serious Adverse Events and Death(Up to 9 months)