Effectiveness and Safety of a 6-Month Treatment With IV Zemplar in Patients on Hemodialysis and With Secondary Hyperparathyroidism Using iPTH/100 as Initial Dose
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- The Percentage of Patients Reaching at Least a 30% Reduction in PTH and/or Values in Range 150-300 pg/mL
研究概览
简要总结
The purpose of this study is to observe the effectiveness and safety of the use of a low initial dose regime (iPTH/100) in chronic kidney disease patients with secondary hyperparathyroidism (PTH>300pg/mL) and that require dialysis at least 3 times per week.
详细描述
The study will be carried out in three dialysis centers in Peru. Each patient enrolled in the study will be followed during a 6 month period from the time of inclusion. Study visits will occur at Baseline and at Weeks 4, 8, 12 and 24 during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Patients >=18 years old with secondary hyperparathyroidism (PTH>300pg/mL, measured in the last 2 weeks).
- •Patients on hemodialysis who require starting therapy with IV paricalcitol (de novo).
- •Patients attending 3 hemodialysis sessions per week.
- •Patients signing the informed consent approved by the Ethics Committee. If any individual is not capable of giving his/her consent, it can be obtained from a next of kin or from his/her legal representative, according to local laws and regulations.
- •The decision to initiate treatment is upon the investigator and the decision to treat patients with IV paricalcitol must not be based on the inclusion of the patient in the study or any other way. The decision to treat a patient with IV paricalcitol will be taken prior to asking the patient to participate in the study.
排除标准
- •Patients with any concomitant clinical condition that, according to the investigator's opinion, might impede an adequate assessment of the treatment response.
- •Patients with severe hyperparathyroidism (PTH>3000pg/mL).
- •Patients with a serum calcium level greater or equal to 10.5mg/dL, phosphorus greater or equal to 6.5mg/dL, or those with Calcium X Phosphorus product 65 (measured at least 2 weeks before the study).
- •Patients with neoplastic disease.
- •Pregnant or lactating women.
- •Known hypersensitivity and/or toxicity to vitamin D metabolites and/or to other ingredients of the product.
- •Having participated in another study with an investigational product or device within the previous 30 days or having planned to participate in another study within the same period of time as the actual study.
- •Use of vitamin D analogue during the last 3 months prior to the inclusion to this study.
研究组 & 干预措施
Zemplar (paracalcitol)
干预措施: Zemplar (paricalcitol) (Drug)
结局指标
主要结局
The Percentage of Patients Reaching at Least a 30% Reduction in PTH and/or Values in Range 150-300 pg/mL
时间窗: 24 weeks
The percentage of participants who achieved at least a 30% reduction in intact parathyroid hormone (iPTH) and/or an iPTH value in the range of 150 to 300 picograms per milliliter (pg/mL) at any post-baseline visit during the study. An iPTH value of 150-300 pg/ml is the target range recommended by the NKF KDOQI (National Kidney Foundation Kidney Disease Outcomes Quality Initiative) for End Stage Renal Disease patients.
次要结局
- Time to Reach the First 30% Reduction in PTH and/or a Value Between 150-300pg/mL(24 Weeks)
- Number of Participants With Hypercalcemia (>10.5mg/dL), Hyperphosphatemia (>6.5mg/dL) and/or Elevations of the Ca X P Product (>65).(24 Weeks)