EUCTR2008-004558-34-ES进行中（未招募）1 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._____________________________________________Estudio aleatorizado para evaluar la eficacia y seguridad del tratamiento con cinacalcet en combinación con bajas dosis de vitamina D para el tratamiento de pacientes con hiperparatiroidismo secundario (HPTS) incidentes en diálisis.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects will be eligible for the study if they meet all of the following criteria:
- •Adults ≥ 18 years of age on hemodialysis for > 3 and ≤ 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 ? 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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects will be ineligible for the study if they fulfill any of the following criteria:
- •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) ≤ 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).
研究者
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