NCT00990704已完成2 期
Phase II, Open Study, Exploratory Examination of Efficacy and Safety of Paricalcitol Injection and Maxacalcitol Injection in Chronic Kidney Disease Subjects Receiving Hemodialysis 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
- Abbott
- 入组人数
- 47
- 试验地点
- 14
- 主要终点
- The Percentage of Participants With a >=50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline Compared to the Average iPTH Obtained in the Last 3 Weeks.
研究概览
简要总结
This study is a exploratory comparison of the efficacy and safety of paricalcitol injection with maxacalcitol injection in chronic kidney disease participants receiving hemodialysis with secondary hyperparathyroidism.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic kidney disease (CKD) patients with iPTH >=300 pg/mL, adjusted calcium >=8.4 to <10.2 mg/dL, and phosphorus <=6.5 mg/dL
- •Patients receiving dialysis 3 times weekly for at least 3 months before informed consent was obtained and scheduled to receive the same hemodialysis during the study period
- •Patients using dialysate with constant concentration of calcium for 4 weeks before informed consent was obtained and receiving phosphate binder with constant dose regimen for 2 weeks before informed consent was obtained
排除标准
- •Patients taking drugs that affect iPTH, calcium, or bone metabolism
- •Patients with a history of allergic reaction or significant sensitivity to vitamin D
- •Patients who received parathyroidectomy or ethanol infusion within 1 year before informed consent was obtained
- •Patients with malignancy or with clinically significant hepatic disease (liver function tests more than 3 times the upper limit of normal) or with refractory hepatic disease
- •Patients with cardiovascular disease designated as New York Heart Association Class III or IV or with any of the following cardiovascular or cerebrovascular diseases within 6 months before informed consent was obtained:
- •Acute coronary syndrome (myocardial infarction or unstable angina) or acute cerebral vascular disease (cerebral infarction or cerebral hemorrhage)
- •Coronary arterial revascularization (such as coronary artery bypass grafting, percutaneous transluminal coronary angioplasty)
- •Cerebral arterial revascularization (such as cerebral aneurysm clipping, cerebral aneurysm embolization, carotid artery endarterectomy)
- •Arteriosclerosis obliterans with rest pain (Fontaine classification III or more severe)
- •Patients with severe hypertension (defined as mean resting blood pressure taken with the patient in a supine position before dialysis and at 6 dialyses sessions before informed consent was obtained: systolic >= 180 mmHg and diastolic >= 110 mmHg)
- •Patients with uncontrolled diabetes mellitus (defined as mean glycosylated hemoglobin >=8% for 3 months before informed consent was obtained)
- •Patients with a history of drug or alcohol abuse within 6 months before informed consent was obtained
- •Patients who require chronic use of cytochrome P450 (CYP3A) inhibitors or inducers
- •Patients who are taking products that contain aluminum 2 weeks before informed consent was obtained
- •Patients who have taken paricalcitol in the past
研究组 & 干预措施
Paricalcitol
Experimental
2 mcg adjusted by +/- 1 mcg, up to a maximum of 7 mcg, administered 3 times per week through intravenous catheter immediately before completion of dialysis
干预措施: paricalcitol (Drug)
Maxacalcitol
Active Comparator
5 or 10 mcg adjusted by +/- 2.5 mcg, up to a maximum of 20 mcg, administered 3 times per week through intravenous catheter immediately before completion of dialysis
干预措施: maxacalcitol (Drug)
结局指标
主要结局
The Percentage of Participants With a >=50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline Compared to the Average iPTH Obtained in the Last 3 Weeks.
时间窗: Baseline and the last 3 weeks (Weeks 11, 12, and 13)
次要结局
- The Percentage of Participants With iPTH Within Target Range of 60-180 pg/mL, Based on the Average iPTH Obtained in the Last 3 Weeks(During the last 3 weeks (Weeks 11, 12, and 13))
- Mean iPTH at Each Visit(Screening (up to 2 weeks before Baseline) to Week 13)
- Mean Change in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks(Baseline and the last 3 weeks (Weeks 11, 12, and 13))
- Percentage of Participants With a >= 50% Reduction in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks and Without Hypercalcemia During Treatment(Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia)
- Percentage of Participants With iPTH Within the Target Range of 60-180 pg/mL Based on the Average iPTH Obtained in the Last 3 Weeks of the Study and Without Hypercalcemia Anytime During Treatment(Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia)
- Number of Occurrences of iPTH Control, Defined as >=50% Reduction in iPTH From Baseline(Over the 12-week treatment period)
- Number of Occurrences of iPTH Control, Defined as Within the Target Range of 60-180 pg/mL of iPTH(Over the 12-week treatment period)
研究者
研究点 (14)
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