A Study to Compare the Efficacy and Safety of an Oral Calcimimetic Agent (AMG 073) When Two Different Vitamin D Regimens Are Used in Subjects With Secondary Hyperparathyroidism of End-Stage Renal Disease (ESRD)

Amgen0 个研究点目标入组 850 人开始时间: 2002年11月1日最近更新: 2010年4月23日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Amgen
入组人数: 850
主要终点: Examine PTH and Ca x P control when cinacalcet is administered in the setting of flexible dosing of vitamin D sterols.

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this research is to study the efficacy and safety of AMG 073 in patients with kidney failure who are being treated with hemodialysis or peritoneal dialysis and who also have secondary hyperparathyroidism (HPT).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
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

•Completed one of the qualifying studies (i.e., patient previously took part in an Amgen study investigating the drug AMG 073 and its effects on secondary hyperparathyroidism [HPT]; in particular parathyroid hormone [PTH], calcium and phosphorus levels in blood associated with kidney failure) - Must agree to use, in the opinion of the principal investigator, highly effective contraceptive measures throughout the study

排除标准

•Pregnant or nursing females - Experienced a myocardial infarction within 3 months before day 1 - Have an unstable medical condition, defined as having been hospitalized, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator

结局指标

主要结局

Examine PTH and Ca x P control when cinacalcet is administered in the setting of flexible dosing of vitamin D sterols.

次要结局

Examine safety and tolerability of cinacalcet.

研究者

发起方

Amgen

申办方类型

Industry

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