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临床试验/CTRI/2009/091/000452
CTRI/2009/091/000452已完成4 期

A single arm open label study to assess the efficacy, safety and tolerability of two weekly administration of intravenous MIRCERA for the treatment of chronic renal anaemia in dialysis patients not currently treated with ESA

Roche Products India Pvt Ltd India16 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2008年4月7日最近更新:
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试验速览

阶段
4 期
状态
已完成
入组人数
220
试验地点
16
主要终点
To assess effectiveness of two-weekly intravenous administration of MIRCERA in dialysis patients with chronic renal anaemia, not currently treated with ESA.
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

分配方式
Not Applicable
盲法
Open Label

入排标准

入选标准

  • •Written informed consent?
  • •Age 18 years or older?
  • •Chronic renal anaemia?
  • •Haemoglobin concentration between 8 g/dL and 10 g/dL?
  • •No prior ESA therapy during the previous 2 months?
  • •Adequate iron status (serum ferritin >100 ng/mL AND TSAT>20% OR hypochromic red cells <10%) ?
  • •Haemodialysis or peritoneal dialysis therapy with the same mode of dialysis for at least the previous 4 Weeks.

排除标准

  • •Blood transfusion during the previous 4 Weeks?
  • •Poorly controlled hypertension, i.e. sitting blood pressure exceeding 170/100 mm of Hg despite medication.
  • •Average of 2 values measured at least two hours apart before dialysis ?
  • •Significant acute or chronic bleeding such as overt gastrointestinal bleeding?
  • •Active malignant disease (except non-melanoma skin cancer)?
  • •History of Haemolysis ?
  • •History of Haemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types)?
  • •Platelet count >500 x 109/L or <100 x 109/L ?
  • •History of Pure red cell aplasia?
  • •Folic acid deficiency, uncorrected in past 2 months?
  • •Vitamin B12 deficiency, uncorrected in past 2 months?
  • •Epileptic seizure during previous 6 months ?
  • •Congestive heart failure (NYHA Class IV)?
  • •Myocardial infarction or stroke, severe or unstable coronary artery disease, severe liver disease during the previous 3 months?
  • •Pregnancy or lactation period?
  • •Women of childbearing potential without effective contraception?
  • •Participation in a clinical trial or receipt of an investigational compound or an investigational treatment during the previous 3 months?
  • •Planned (date) elective surgery during the study period.

结局指标

主要结局

To assess effectiveness of two-weekly intravenous administration of MIRCERA in dialysis patients with chronic renal anaemia, not currently treated with ESA.

时间窗: ? Mean change in Hb concentration from baseline (week 0) and last visit (week 16) of the TP

次要结局

  • To evaluate the safety and tolerability of MIRCERA two weekly dosing in the treatment of anaemia in patients with chronic kidney disease.(? Time to achievement of response (achievement of Hb levels within target range i.e. 10.0 ? 12.0 g/dL)? The percentage of patients whose average Hb concentration is within the range 10.0 ? 12.0 g/dL in the last 4 weeks of TP? Mean time spent in Hb range of 10.0 ? 12.0 g/dL during the last 4 weeks of TP)

研究者

申办方类型
Pharmaceutical industry-Indian

研究点 (16)

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