NCT00442793已完成3 期
A Randomized, Open Label Study Comparing the Effect of Mircera and Epoetin Beta on Hemoglobin Response in Patients With Chronic Kidney Disease Who Are on Dialysis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 265
- 主要终点
- Hb response rate
研究概览
简要总结
This 2 arm study will compare the effect on hemoglobin response of Mircera and epoetin beta, in patients with chronic renal anemia who are on dialysis. Eligible patients will be randomized to receive either Mircera (0.4 micrograms/kg i.v. every 2 weeks) or epoetin beta (3 times weekly, according to approved labelling). 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 requiring dialysis;
- •maintenance hemodialysis or peritoneal dialysis for >=2 weeks before and during screening;
- •adequate iron status.
排除标准
- •previous epoetin treatment within 8 weeks prior to screening;
- •failing renal graft in place;
- •bleeding episode necessitating transfusion within 8 weeks prior to screening;
- •poorly controlled hypertension;
- •previous treatment with Mircera.
研究组 & 干预措施
1
Experimental
干预措施: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
2
Active Comparator
干预措施: Epoetin beta (Drug)
结局指标
主要结局
Hb response rate
时间窗: Weeks 0-24
Change in Hb concentration between baseline and evaluation period
时间窗: Months 4-6
次要结局
- Hb over time(Throughout study)
- Serum concentration of Mircera(Throughout study)
- Time to Hb response(Throughout study)
- RBC transfusions(Weeks 0-24)
- AEs, laboratory parameters, vital signs(Throughout study)
研究者
相似试验
终止
3 期
A Study of Mircera in Hemoglobin Control of Patients Transitioning to Dialysis.AnemiaNCT00454246Hoffmann-La Roche111
已完成
3 期
A Study of Mircera for the Maintenance Treatment of Anemia in Dialysis PatientsAnemiaNCT00394953Hoffmann-La Roche490
终止
2 期
A Study Comparing Two Different PROCRIT Doses to a Dose of ARANESP in Anemic Cancer Patients Receiving ChemotherapyNeoplasmsCancerAnemiaNCT00386152Johnson & Johnson Pharmaceutical Research & Development, L.L.C.235
已完成
4 期
Hematologic Response of Epoetin Alfa (PROCRIT) Versus Darbepoetin Alfa (ARANESP) in Chemotherapy Induced AnemiaChemotherapyAnemiaNCT00315484Ortho Biotech Products, L.P.358
已完成
3 期
A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease, Not on Dialysis.AnemiaNCT00442702Hoffmann-La Roche228