NCT00452478终止4 期
A Phase IV, Open-Label, Multi-Centre Trial Evaluating the Conversion From Standard Phosphate Binder Therapy to Fosrenol® in Chronic Kidney Disease Stage 5 Patients on Haemodialysis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Shire
- 入组人数
- 68
- 试验地点
- 14
- 主要终点
- Percentage of subjects achieving serum phosphorus levels of less than or equal to 1.78 mmol/L (5.5 mg/dL) following treatment with Fosrenol at Week 12 compared to treatment with their previous phosphate binder therapy
研究概览
简要总结
The main aim of this research study is to see if giving Fosrenol®, a chewable tablet, to patients on haemodialysis works as well as other treatments currently used to lower blood phosphorus levels.
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
- •Male or female subjects greater than or equal to 18 years of age receiving a stable regimen of haemodialysis for chronic kidney disease (CKD) Stage 5 (defined as haemodialysis two or three times per week for at least two months prior to screening).
- •Females of child bearing potential (FOCP) must be non-pregnant, non-lactating, have a negative serum beta human chorionic gonadotropin (HCG) test, and agree to comply with any applicable contraceptive requirements of the protocol.
- •Subjects on a stable phosphate binder dose (defined as no change in medication or dosage for at least the one month prior to screening) with a serum phosphorus level between greater than 1.78 and less than or equal to 2.43 mmol/L (5.5 and 7.5 mg/dL).
排除标准
- •Subjects with a corrected serum calcium level less than 2.1 mmol/L (8.5 mg/dL).
- •Subjects with an intact parathyroid hormone (iPTH) level greater than 500 pg/mL, or a history of previous parathyroidectomy within 12 months of screening.
- •Subjects with any significant bowel obstruction, active inflammatory bowel disease, gastrointestinal (GI) motility disorders, abnormal or irregular bowel motion, or a history of major GI surgery within the last 6 months will be excluded.
- •Subjects receiving aluminium, magnesium, or combination therapy other than sevelamer hydrogen chloride (HCl) and calcium as a phosphate binder at the time of screening will be excluded.
研究组 & 干预措施
1
Experimental
干预措施: Lanthanum carbonate (Drug)
结局指标
主要结局
Percentage of subjects achieving serum phosphorus levels of less than or equal to 1.78 mmol/L (5.5 mg/dL) following treatment with Fosrenol at Week 12 compared to treatment with their previous phosphate binder therapy
时间窗: 12 weeks
次要结局
- The maintenance of mean serum phosphorus levels following treatment with 2250 mg/day of Fosrenol(at Week 2 compared to baseline)
- Assess safety & tolerability(Throughout the study)
- Biochemical and haematological parameters(measured throughout the study)
研究者
研究点 (14)
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