NCT00527085已完成2 期
A Multicenter, Randomized, Placebo-controlled, Double-blind, 12-month Study to Assess the Effects of an Oral Calcimimetic Agent (AMG 073) on Renal Osteodystrophy in Hemodialysis Patients With Secondary Hyperparathyroidism
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 45
- 主要终点
- To evaluate the effects of AMG 073 compared with placebo on renal osteodystrophy as assessed by bone histomorphometry
研究概览
简要总结
4 doses of AMG 073 or placebo over 52 weeks after a 30-day screening period. Throughout the study, labs will be drawn to measure analytes such as iPTH and corrected calcium. In addition, a bone biopsy will be performed at screening and at the end of study.
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
- Triple (Participant, Care Provider, Investigator)
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
- •18 years of age of greater
- •Using effective contraceptive measures
- •iPTH greater than or equal to 300 pg/mL
- •Serum Calcium greater than or equal to 8.4 mg/dL; Hemoglobin greater than 9
- •Stable hemodialysis for 1 month prior to day 1
排除标准
- •Any unstable medical condition
- •Pregnant or nursing women Recent parathyroidectomy
- •Change in Vitamin D therapy
- •Recent MI, Seizure, Malignancy, GI Disorder
- •Inability to swallow tablets
研究组 & 干预措施
AMG 073
Experimental
干预措施: AMG 073 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
To evaluate the effects of AMG 073 compared with placebo on renal osteodystrophy as assessed by bone histomorphometry
时间窗: entire study
次要结局
- To evaluate the effects of AMG 073 compared with placebo on intact parathyroid hormone (iPTH), bone-specific alkaline phosphatase (BALP), serum N-Telopeptide (N-Tx), and calcium x phosphorus product concentrations(entire study)
- To evaluate the feasibility of measuring physical activity with accelerometry(entire study)
- To evaluate the safety and tolerability of AMG 073 compared with placebo(entire study)
研究者
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