NCT00530114已完成2 期
A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Fixed Dose Study of AMG 223 in Subjects With Chronic Kidney Disease on Hemodialysis With Hyperphosphatemia
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
- 167
- 主要终点
- To demonstrate the AMG 223 will produce a statistically significant reduction in serum phosphorus compared with placebo over a 3 week treatment period in subjects with CKD receiving dialysis
研究概览
简要总结
The primary objectives of this study are the following:
- To demonstrate that AMG 223 will produce a statistically significant reduction in serum phosphorus compared with placebo over a 3 week treatment period in subjects with CKD receiving dialysis
- To describe a dose response for AMG 223
- To evaluate the safety and tolerability of AMG 223
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
- •Maintenance hemodialysis 3 times a week for at least 3 months prior to screening
- •Single pool Kt/V at least 1.2 or urea reduction ratio at least 65%
- •Serum phosphorus level of 3.5 to 6.5 mg/dL inclusive at screening
- •No change(s) in type or dose of non-investigational phosphate binder(s) for at least 1 month prior to screening
- •Serum albumin > 3.0 mg/dL at screening
- •If applicable, an increase in serum phosphorus of greater than or equal to 1.5 mg/dL, and a serum phophorous level > 5.5 mg/dL and less than or equal to 10 mg/dl during the washout period
- •If applicable, stable doses (defined as no change in dose for at least 1 month prior to screening) of Vitamin D replacement, calcimimetic agents, or bedtime calcium supplements
- •Willingness to avoid intentional changes in diet such as fasting or dieting
排除标准
- •Previous intolerance leading to discontinuation of polymer-based phosphate binder therapy
- •History of noncompliance with phosphate binder therapy in the opinion of the investigator
- •Anticipating or scheduled for a living related-donor kidney transplant, or a prior recipient of a kidney transplant
- •Current use of antiarrhythmic or anti-seizure medication
- •Active ethanol or drug dependence or abuse, excluding tobacco use
- •A screening serum calcium (corrected for albumin) < 8.4 mg/dL
- •History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders, major gastrointestinal surgery, or gastric/duodenal ulcers within 6 months prior to screening
- •Subject is pregnant, breast feeding, or is of child bearing potential and is not using adequate contraceptive precautions
- •Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s)
- •Subject has experienced a myocardial infarction or major surgery (excluding vascular access surgery) within 3 months prior to screening
- •Clinical evidence of current malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of localized basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia
研究组 & 干预措施
Placebo
Placebo Comparator
1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally
干预措施: Placebo (Drug)
AMG 223
Experimental
1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally
干预措施: AMG 223 (Drug)
结局指标
主要结局
To demonstrate the AMG 223 will produce a statistically significant reduction in serum phosphorus compared with placebo over a 3 week treatment period in subjects with CKD receiving dialysis
时间窗: TREATMENT PERIOD
次要结局
- To evaluate the safety and tolerability of AMG 223(ENTIRE STUDY)
- To describe a dose response for AMG 223(TREATMENT PERIOD)
研究者
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