A Phase 3b, Randomized, Active-Controlled, Single-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Paricalcitol Injection in Reducing Serum Intact Parathyroid Hormone Levels in Chronic Kidney Disease Stage 5 Subjects Receiving Hemodialysis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 216
- 试验地点
- 12
- 主要终点
- The Achievement of Two Consecutive Greater Than or Equal to 30% Decreases From Baseline Intact Parathyroid Hormone Levels
研究概览
简要总结
Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease
详细描述
Evaluate the safety and efficacy of paricalcitol injection with two different dosing regimens (currently approved dosing regimen used in the US package insert versus dosing based on a formula of iPTH/80 that was approved and used in the EU package insert) in Chronic Kidney Disease (CKD) Stage 5 subjects with secondary hyperparathyroidism receiving hemodialysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Subject is a Chinese male or female greater than or equal to 20 years old.
- •Subject is diagnosed with Chronic Kidney Disease Stage 5 and must be on maintenance hemodialysis three times a week for at least 2 months prior to the Screening Visit and expected to remain on hemodialysis for the duration of the study.
- •For entry into the Treatment Phase, the subject must have:
- •Intact parathyroid hormone greater than or equal to 300 pg/mL
- •Serum calcium less than 10.2 mg/dL (2.55 mmol/L)
- •Calcium-phosphorus product less than 65 mg^2/dL^2
排除标准
- •Subject has a history of an allergic reaction or significant sensitivity to vitamin D or vitamin D related compounds.
- •Subject received a partial parathyroidectomy within one year prior to the Screening Phase.
- •Subject with New York Heart Association (NYHA) Class III or IV.
- •Subject has taken aluminum-containing phosphate binders for greater than 3 weeks in the last 3 months prior to the Screening Phase, or requires such medications for greater than 3 weeks in the study.
- •Subject has a current malignancy (with the exception of basal or squamous cell carcinoma of the skin), or clinically significant liver disease, in the opinion of the Investigator.
- •Subject has a history of drug or alcohol abuse within 6 months prior to the Screening Phase.
- •Subject is known to be human immunodeficiency virus (HIV) positive.
- •Subject has evidence of poor compliance with diet, medication or hemodialysis that may interfere, in the Investigator's opinion, with adherence to the protocol.
研究组 & 干预措施
Group 1
Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
干预措施: paricalcitol (Drug)
Group 2
Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
干预措施: paricalcitol (Drug)
结局指标
主要结局
The Achievement of Two Consecutive Greater Than or Equal to 30% Decreases From Baseline Intact Parathyroid Hormone Levels
时间窗: Baseline to 12 Weeks
The number of participants who achieved (Yes) or did not achieve (No) two consecutive decreases of greater than or equal to 30% from baseline in intact parathyroid hormone (iPTH) values
次要结局
- The Proportion of Subjects Achieving a Final Intact Parathyroid Hormone Value Between 150 and 300 pg/mL(Baseline to 12 Weeks)
- The Change From Baseline to the Final Observation in Intact Parathyroid Hormone Value(Baseline to 12 Weeks)
- The Change From Baseline to the Final Observation in Calcium(Baseline to 12 Weeks)
- The Change From Baseline to the Final Observation in Calcium-phosphorus Product(Baseline to 12 Weeks)
- The Change From Baseline to the Final Observation in the Vital Sign of Systolic Blood Pressure(Baseline to 12 Weeks)
- The Change From Baseline to the Final Observation in the Vital Sign of Diastolic Blood Pressure(Baseline to 12 Weeks)
- The Change From Baseline to the Final Observation in the Vital Sign of Heart Rate(Baseline to 12 Weeks)
- The Proportion of Subjects With 2 Consecutive Calcium Measurements Greater Than 11.0 mg/dL (2.75 mmol/L)(Baseline to 12 weeks)