NCT00824460已完成2 期
An Open-label, Randomised, Active Controlled Multi-center Phase II Dose Finding Study to Evaluate the Ability of PA21 to Lower Serum Phosphate Levels and the Tolerability in Patients With Chronic Kidney Disease on Maintenance Hemodialysis
Vifor Pharma56 个研究点 分布在 8 个国家目标入组 154 人开始时间: 2008年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 154
- 试验地点
- 56
- 主要终点
- Change From Baseline in Serum-phosphate Levels at the End of Treatment.
研究概览
简要总结
The purpose of this study is to investigate the ability of different doses of PA21 to lower serum phosphate levels, in patients with chronic kidney disease on maintenance 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
- •≥ 18 years of age,
- •Receiving stable maintenance hemodialysis 3 times a week
- •On restricted phosphate diet at screening and throughout study
- •Receiving stable dose of phosphate binder for at least 1 month
- •Serum phosphate levels >1.78 mmol/L
排除标准
- •Uncontrolled hyperphosphatemia
- •Hypercalcemia at screening or during washout
- •Serum calcium < 1.9 mmol/L (<7.6 mg/dL)
- •Severe hyperparathyroidism (iPTH levels >600 ng/L)
- •Pregnancy or lactation
- •Iron deficiency anemia
- •History of hemochromatosis or ferritin >800 mg/L,
- •Hepatitis B, hepatitis C or other significant concurrent liver disorders
- •Known positivity to HIV
- •Use of oral iron preparations 1 month before screening,
- •Serious medical condition or uncontrolled systemic disease
研究组 & 干预措施
12.5 g PA21
Experimental
干预措施: 12.5 g PA21 (2,500 mg iron) (Drug)
1.25 g PA21
Experimental
干预措施: 1.25 g PA21 (250 mg iron) (Drug)
5.0 g PA21
Experimental
干预措施: 5.0 g PA21 (1,000 mg iron) (Drug)
7.5 g PA21
Experimental
干预措施: 7.5 g PA21 (1,500 mg iron) (Drug)
10.0 g PA21
Experimental
干预措施: 10.0 g PA21 (2,000 mg iron) (Drug)
Sevelamer hydrochloride - active control
Experimental
干预措施: Sevelamer hydrochloride (Drug)
结局指标
主要结局
Change From Baseline in Serum-phosphate Levels at the End of Treatment.
时间窗: 6 weeks after baseline
次要结局
- Change From Baseline in Serum-phosphate Levels at Week 2(2 weeks after baseline)
- Change From Baseline in Serum-phosphate Levels at Week 4(4 weeks after baseline)
- Change From Baseline in Serum-phosphate Levels at Week 5(5 weeks after baseline)
研究者
研究点 (56)
Loading locations...
相似试验
已完成
3 期
A Phase III Study of PA21 in Peritoneal Dialysis Patients With HyperphosphatemiaPeritoneal DialysisHyperphosphatemiaNCT01852682Kissei Pharmaceutical Co., Ltd.
已完成
3 期
PA21 Safety and Efficacy in Adult Chinese SubjectsChronic Kidney Disease Requiring Chronic DialysisHyperphosphatemiaNCT03644264Vifor Fresenius Medical Care Renal Pharma286
已完成
1 期
A Drug-Drug Interaction Study of Omeprazole and PA21HealthyNCT01452906Vifor Pharma45
已完成
3 期
A Phase III Study of PA21 in Hemodialysis Patients With HyperphosphatemiaHemodialysisHyperphosphatemiaNCT01850602Kissei Pharmaceutical Co., Ltd.213
已完成
1 期
A Drug-Drug Interaction Study of Warfarin and PA21Drug Interaction PotentiationNCT01477424Vifor Pharma45