NCT00048438已完成3 期
Safety and Efficacy of Zemplar Capsule in Reducing Serum IPTH Levels in Chronic Kidney Disease Subjects (Three Times Weekly)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 68
- 试验地点
- 34
- 主要终点
- The efficacy endpoint is achievement of two consecutive > or = 30% decreases from baseline iPTH levels.
研究概览
简要总结
The objective of this study is to determine whether paricalcitol is safe and effective compared to placebo in reducing elevated serum PTH levels in patients with chronic kidney disease.
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
- Double
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
- •Under care of physician at least 2 months (for CKD)
- •Not on active Vitamin D therapy for at least 4 weeks prior
- •If female:
- •Not of childbearing potential, OR
- •Practicing birth control
- •Not breastfeeding
- •If taking phosphate binders, on a stable regimen at least 4 weeks prior
- •For entry into Pretreatment Phase:
- •iPTH at least 120 pg/mL
- •GFR of 15-60 mL/min and no dialysis expected for at least 6 months
- •For entry into Treatment Phase:
- •Average of 2 consecutive iPTH values of at least 150 pg/mL, taken at least 1 day apart (all values not less than 120 pg/mL
- •2 consecutive corrected serum calcium levels between 8.0-10.0 mg/dL
- •2 consecutive serum phosphorus levels of not more than 5.2 mg/mL
排除标准
- •History of allergic reaction or sensitivity to similar drugs
- •Acute Renal Failure within 12 weeks of study
- •Chronic gastrointestinal disease
- •Spot urine result demonstrating a urine-calcium-to-urine creatinine ratio of greater than 0.2, or a history of renal stones
- •Taken aluminum-containing phosphate binders within last 12 weeks, or requires such medication for more than 3 weeks during study
- •Current malignancy, or clinically significant liver disease
- •Active granulomatous disease (TB, sarcoidosis, etc.)
- •History of drug or alcohol abuse within 6 mos. prior
- •Evidence of poor compliance with diet or medication
- •Received any investigational drug or participated in any device trial within 30 days prior
- •Taking maintenance calcitonin, bisphosphonates, or drugs that may affect calcium or bone metabolism (other than females on stable estrogen and/or progestin therapy)
- •On glucocorticoids for a period of more than 14 days within the last 6 months
- •HIV positive
结局指标
主要结局
The efficacy endpoint is achievement of two consecutive > or = 30% decreases from baseline iPTH levels.
次要结局
未报告次要终点
研究者
研究点 (34)
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