Phase 4 Study of Cinacalcet Efficacy in Combination With Vitamin D for the Treatment of Secondary Hyperparathyroidism in Peritoneal Dialysis Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 7
- 主要终点
- > 30% reduction from baseline of intact parathyroid hormone (iPTH)
研究概览
简要总结
This study is designed in order to investigate the effect of cinacalcet in combination with routine conventional medical management for treatment of secondary hyperparathyroidism (SHPT) and Ca, P control. This study will compare the efficacy of a cinacalcet-based regimen with unrestricted conventional care (vitamin D and phosphate binders) for achieving the stringent National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI) targets for dialysis patients.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Peritoneal dialysis patients with secondary HPT(iPTH > 300 pg/mL)
- •> 18 yr of age, < 70
- •had receive PD for > 3 mo,
- •intact PTH level > 300 pg/ml and <1000 pg/ml
- •albumin corrected Ca level >= 9.0 mg/dL
排除标准
- •pregnant or breast-feeding,
- •had undergone parathyroidectomy within previous 3 mo,
- •are involved in other clinical trial within 30 d
- •had received cinacalcet therapy previously.
研究组 & 干预措施
Cinacalcet
stepwise dose of cinacalcet + regular medical medication including vit D
干预措施: cinacalcet (Drug)
Control
conventional treatment for secondary HPT including vit D and phosphate binder
干预措施: control (Drug)
结局指标
主要结局
> 30% reduction from baseline of intact parathyroid hormone (iPTH)
时间窗: 20 weeks
次要结局
- Achievement of treatment goal of intact parathyroid hormone (iPTH) (150~300 pg/ml)(20 weeks)
- Achievement of targets for mean Ca x P (<55 mg2/dL2), Ca (<9.5 mg/dL), P (<5.5 mg/dL)(20 weeks)
- Achieving targets for intact PTH (150-300 pg/ml) and calcium-phosphorus product (Ca x P) (<55 mg2/dl2) simultaneously(20 weeks)
- Vascular calcification score(20 weeks)
- Normalization of serum alkaline phosphatase(20 weeks)
- Serum FGF-23(baseline and 20th week)
研究者
Kook-Hwan Oh
Associate Professor
Seoul National University Hospital