A Randomized Study of the Safety and Efficacy of FG-2216 in Subjects With Renal Anemia Not Requiring Dialysis and Not Receiving Recombinant Human Erythropoietin

Kyntra Bio27 个研究点分布在 1 个国家目标入组 145 人开始时间: 2005年12月1日最近更新: 2007年11月6日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Kyntra Bio
入组人数: 145
试验地点: 27
主要终点: Hemoglobin (Hb) response

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

The purpose of this study is to test the safety and efficacy of FG-2216 in the treatment of patients with renal anemia who are not receiving erythropoietin and who are not on dialysis.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Factorial
主要目的: Treatment
盲法: Single

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

•Stage 3 or 4 chronic kidney disease
•appropriate hemoglobin levels

排除标准

•Neovascular age related macular degeneration requiring treatment
•Macular edema or proliferative retinopathy in diabetic subjects, requiring treatment
•Any history of malignancy
•Therapy with recombinant erythropoietin or red blood cell transfusion within 4 weeks
•Renal Transplant

结局指标

主要结局

Hemoglobin (Hb) response

次要结局

Attainment of Hb target range (11-13)
Duration of maintenance of Hb in target range (11-13)
Safety

研究者

发起方

Kyntra Bio

申办方类型

Industry

研究点 (27)

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