NCT00803712已完成4 期
Randomized Trial to Evaluate the Efficacy and Safety of Cinacalcet Treatment in Combination With Low Dose Vitamin D for the Treatment of Subjects With Secondary Hyperparathyroidism (SHPT) Recently Initiating Hemodialysis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 313
- 主要终点
- Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
研究概览
简要总结
Randomized Trial to Evaluate the Efficacy and Safety of Cinacalcet Treatment in Combination with Low Dose Vitamin D for the Treatment of Subjects with Secondary Hyperparathyroidism (SHPT) Recently Initiating Hemodialysis
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults greater than or equal to 18 years of age on hemodialysis for > 3 and less than or equal to 12 months prior to enrollment into the study
- •Mean of 2 PTH determinations during the screening period (drawn at least 2 days apart) > 300 pg/mL (31.8 pmol/L); or biPTH > 160 pg/mL (17.0 pmol/L)
- •Mean of 2 corrected serum calcium determinations drawn on the same day as the PTH determinations greater than or equal to 8.4 mg/dL (2.1 mmol/L)
- •Subject will be able to complete the study, to the best of his/her knowledge
- •Before any study-specific procedure, the appropriate written informed consent must be obtained
排除标准
- •Mean of 2 PTH determinations during the screening period (drawn at least 2 days apart) > 800 pg/mL (84.9 pmol/L); or biPTH > 430 pg/mL (45.6 pmol/L) AND receiving vitamin D on entering screening
- •Parathyroidectomy (partial or full) less than or equal to 6 months before entering screening
- •Anticipated parathyroidectomy (partial or full) within 6 months after randomization
- •Have a scheduled date for kidney transplant surgery
- •Received cinacalcet since initiating hemodialysis
- •Have received vitamin D therapy for less than 30 days before entering screening or required a change in prescribed vitamin D brand or dose within 30 days before entering screening. If subjects are not receiving vitamin D therapy, they must remain free of vitamin D therapy for the 30 days before entering screening
- •Subject is pregnant (eg, positive HCG test) or is breast-feeding
- •Refusal to use highly effective contraceptive measures (as determined by the investigator) throughout the study (screening and post enrollment)
- •Current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets
- •Known sensitivity, intolerance, or other adverse response to cinacalcet which would prevent on-study treatment compliance
- •Have an unstable medical condition within 30 days before screening, or otherwise unstable in the judgment of the investigator
- •Subject is currently enrolled in, or fewer than 30 days prior to entering screening have passed since subject received other investigational agent(s) (devices or drug).
研究组 & 干预措施
Cinacalcet Group
Experimental
Cinacalcet plus low dose active Vitamin D (if prescribed)
干预措施: Cinacalcet (Drug)
Control Group
Active Comparator
Flexible active vitamin D dosing
干预措施: Vitamin D (Drug)
结局指标
主要结局
Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
时间窗: Weeks 22-26
All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For participants with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
次要结局
- Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)(Weeks 48-52)
- Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)(Weeks 22-26)
- Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)(Weeks 48-52)
- Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)(Weeks 22-26 and Weeks 48-52)
- Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 12 Efficacy Assessment Phase(Weeks 48-52)
- Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)(Weeks 22-26)
- Achievement of a >= 30% Reduction in Mean iPTH From Baseline to During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)(Weeks 22-26 and Weeks 48-52)
- Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)(Weeks 22-26 and Weeks 48-52)
- Summary of iPTH (pg/mL) at Month 6 Efficacy Assessment Phase(Weeks 22-26)
- Summary of Corrected Serum Calcium (mg/dL) at Month 12 Efficacy Assessment Phase(Weeks 48-52)
- Subject Incidence of Hypercalcemia During the Maintenance Phase(Weeks 26-48)
- Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)(Weeks 22-26)
- Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)(Weeks 48-52)
- Achievement of a Mean iPTH <=300 pg/mL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)(Weeks 22-26 and Weeks 48-52)
- Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)(Weeks 48-52)
- Summary of Corrected Serum Calcium (mg/dL) at Month 6 Efficacy Assessment Phase(Weeks 22-26)
- Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 12 Efficacy Assessment Phase(Weeks 48-52)
- Summary of Serum Phosphorus (mg/dL) at Month 12 Efficacy Assessment Phase(Weeks 48-52)
- Summary of Percent Change From Baseline in Serum Phosphorus at Month 12 Efficacy Assessment Phase(Weeks 48-52)
- Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 6 Efficacy Assessment Phase(Weeks 22-26)
- Summary of iPTH (pg/mL) at Month 12 Efficacy Assessment Phase(Weeks 48-52)
- Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 12(Weeks 48-52)
- Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 6 Efficacy Assessment Phase(Weeks 22-26)
- Summary of Percent Change From Baseline in Serum Phosphorus at Month 6 Efficacy Assessment Phase(Weeks 22-26)
- Summary of Serum Phosphorus (mg/dL) at Month 6 Efficacy Assessment Phase(Weeks 22-26)
- Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 6(Weeks 22-26)
- Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 6(Weeks 22-26)
- Subject Incidence of Hyperphosphatemia During the Maintenance Phase(Weeks 26-48)
- Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 12(Weeks 48-52)
研究者
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