A Double-Blind, Cross-Over Design Study of Sevelamer Hydrochloride (Renagel®) and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 主要终点
- Safety-evaluated on the basis of adverse events (reported and/or observed)
研究概览
简要总结
This is a double-blind, randomized, cross-over study conducted at centers within the United States. The study consists of five periods: an up to two-week Screening Period, a 5-week Run-In Period, two eight-week study treatment periods and a two-week Washout Period. Patients are assigned randomly (1:1) to one of two treatment sequences: sevelamer carbonate for eight weeks followed by sevelamer hydrochloride for eight weeks or sevelamer hydrochloride for eight weeks followed by sevelamer carbonate for eight weeks
详细描述
The study was conducted at 15 centers (2 of which did not enroll any patients). A total of 79 hemodialysis patients were assigned randomly to one of two treatment sequences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •patient had received hemodialysis three times per week for 3 months or longer;
- •patients were maintained on sevelamer hydrochloride as their primary phosphate binder with a total daily dose of ≤ 13.6 g with serum phosphorus concentrations at the last two measurements between 3.0 and 6.5 mg/dL, the most recent iPTH ≤ 600 pg/mL and the most recent serum calcium within the normal range.
排除标准
- •if patient had active bowel obstruction, dysphagia, swallowing disorders, or severe gastrointestinal motility disorders;
- •active ethanol or drug abuse (excluding tobacco);
- •need for antidysrhythmic or antiseizure medications used to control these conditions;
- •poorly controlled diabetes mellitus or hypertension;
- •active vasculitis;
- •active malignancy other than basal-cell carcinoma;
- •HIV infection; or
- •any clinically significant unstable medical condition as judge by the Investigator.
研究组 & 干预措施
1
sevelamer carbonate w(1-8) sevelamer hydrochloride w(9-16)
干预措施: sevelamer carbonate, sevelamer hydrochloride (Drug)
2
sevelamer hydrochloride w(1-8) sevelamer carbonate w(9-16)
干预措施: sevelamer hydrochloride, sevelamer carbonate (Drug)
结局指标
主要结局
Safety-evaluated on the basis of adverse events (reported and/or observed)
时间窗: 16 weeks
changes in laboratory parameters, vital signs
时间窗: 16 weeks
note: clinically significant changes in physical examination were recorded and evaluated as adverse events
时间窗: 16 weeks
Efficacy-treatment regimens are compared on the basis of serum phosphorus at the end of each treatment period using the time-weighted mean of the phosphorus value from the last three visits in each treatment period
时间窗: 16 weeks
Treatment regimens were also compared with respect to total, LDL, and HDL cholesterol, and triglycerides, using the mean of values for each parameter from the two post-baseline assessments in each treatment period.
时间窗: 16 weeks
次要结局
未报告次要终点