NCT01464931已完成1 期
An Open-label Study to Evaluate the Safety of Multiple Doses of Denosumab 120 mg Administered Subcutaneously in Subjects With Severe Chronic Kidney Disease (CKD) and CKD on Dialysis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of Participants With Clinically Significant Hypocalcemia
研究概览
简要总结
The primary objective was to evaluate the incidence of clinically significant hypocalcemia following multiple 120 mg subcutaneous doses of denosumab in patients with severe chronic kidney disease (CKD) and CKD on dialysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Subjects at least 18 years old with severe CKD (defined as creatinine clearance < 30 mL/min at both screening assessments) and CKD requiring hemodialysis
- •Additional inclusion criteria apply
排除标准
- •Subjects must have calcium, phosphate, and magnesium levels appropriate for their condition and must not have other uncontrolled co-morbidities.
- •Additional exclusion criteria apply
研究组 & 干预措施
Denosumab
Experimental
Participants received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
干预措施: Denosumab (Drug)
结局指标
主要结局
Number of Participants With Clinically Significant Hypocalcemia
时间窗: 113 days
Clinically significant hypocalcemia is defined as albumin-adjusted calcium \< 7.0 mg/dL or symptomatic hypocalcemia. Symptomatic hypocalcemiais is defined as both a clinical adverse event of hypocalcemia and a concomitant symptom of hypocalcemia (e.g., hypoesthesia, paresthesia, muscle cramps, seizure, prolonged QT interval) that occurred along with the hypocalcemia event or decreased serum calcium levels.
次要结局
- Number of Participants With Adverse Events(113 days)
- Area Under the Serum Concentration-time Curve From Time 0 to 4 Weeks (AUC0-4wks) After Dose 1(Days 1, 8, 15, and 29 (predose))
- Number of Participants Who Developed Anti-denosumab Antibodies(From Day 1 (predose) to Day 113)
- Number of Participants With Hypomagnesemia Determined by CTCAE v.4.0 Criteria(113 days)
- Maximum Observed Serum Denosumab Concentration (Cmax)(Days 1 and 29 (predose), and on Days 8, 15, 36, 43, 57, 71, 85, and 113)
- Percent Change From Baseline in Serum Phosphorus Over Time(Baseline and Days 2, 3, 6, 8, 11, 15, 22, 29, 30, 31, 34, 36, 39, 43, 57, 71, 85, and 113)
- Number of Participants With Hypocalcemia Determined by CTCAE v.4.0 Criteria(113 days)
- Number of Participants With Hypophosphatemia Determined by CTCAE v.4.0 Criteria(113 days)
- Time to Maximum Observed Serum Denosumab Concentration (Tmax)(Days 1 and 29 (predose), and on Days 8, 15, 36, 43, 57, 71, 85, and 113)
- Area Under the Serum Concentration-time Curve From Time 0 to 12 Weeks (AUC0-12wks) After Dose 2(Days 29 (predose), 36, 43, 57, 71, and 85)
- Percent Change From Baseline in Albumin-adjusted Serum Calcium Over Time(Baseline and Days 2, 3, 6, 8, 11, 15, 22, 29, 30, 31, 34, 36, 39, 43, 57, 71, 85, and 113)
- Percent Change From Baseline in Serum Magnesium Over Time(Baseline and Days 2, 3, 6, 8, 11, 15, 22, 29, 30, 31, 34, 36, 39, 43, 57, 71, 85, and 113)
- Percent Change From Baseline in Serum C-Telopeptide Over Time(Baseline and Days 1 and 29 (predose), and on Days 8, 15, 36, 43, 57, 71, 85, and 113)
研究者
研究点 (1)
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