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临床试验/NCT00364260
NCT00364260已完成3 期

A Study to Determine the Impact of Hemoglobin Maintenance and Other Interventional Strategies to Prevent or Delay the Progression of Left Ventricular Mass Growth in Subjects With Early Renal Insufficiency.

Janssen-Ortho Inc., Canada0 个研究点目标入组 172 人开始时间: 1997年12月1日最近更新:
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试验速览

阶段
3 期
状态
已完成
发起方
入组人数
172
主要终点
The change in left ventricular mass index from baseline to 24 months as measured by 2-dimensional targeted M-mode echocardiography.

研究概览

简要总结

The purpose of this study is to determine if using Eprex, to maintain hemoglobin within the normal range, will prevent or delay the progression of left ventricular mass growth.

详细描述

Cardiovascular disease continues to be the major cause of morbidity and mortality in subjects with renal (kidney) disease. Left ventricular hypertrophy (LVH) has been correlated with a high risk of cardiac and all cause mortality. In the renal population , many factors have been shown to be important in the development of LVH, including anemia. This is a multicentre, open, controlled, randomized trial to determine if maintaining hemoglobin within the normal range delays the progress of left ventricular mass growth. Additionally, this study will evaluated the safety of maintaining hemoglobin within the normal range in pre-dialysis subjects. The trial duration is 24 months. Subjects randomized to the treatment arm will receive Eprex therapy to maintain hemoglobin between 120-140 g/L. Subjects randomized to the control arm will not receive any treatment unless their hemoglobin falls to less than or equal to 90 g/L. Those subjects will then be treated to maintain their hemoglobin between 90-105 g/L. The subjects were to receive injections of Eprex once weekly to maintain hemoglobin levels within the target range for the arm to which they were randomized. The subjects were to receive treatment for up to 24 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients have had a decrease in hemoglobin >= 10 g/L within the past 12 months and a current hemoglobin level between 110-135 g/L (men) and 100-135 g/L (women) OR a hemoglobin level between 115-125 g/L (men) and 110-120 g/L (women)
  • Have a calculated creatinine clearance <80 mL/min and >15 mL/min

排除标准

  • No uncontrolled hypertension (diastolic blood pressure>= 105 mm Hg on average for the previous month)
  • No unstable angina or cardiac procedure within the past 12 months or a planned procedure
  • No myocardial infarction with the past 12 months

结局指标

主要结局

The change in left ventricular mass index from baseline to 24 months as measured by 2-dimensional targeted M-mode echocardiography.

次要结局

  • The difference in renal function (calculated creatinine clearance) between groups at 24 months; The functional cardiac status (NYHA/CCS classification) between groups at 24 months;The change in SF-36 scores between groups from baseline to 24 months

研究者

发起方
Janssen-Ortho Inc., Canada
申办方类型
Industry

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