A Long-Term, Open Label Study to Evaluate the Ability of Tenapanor Alone or in Combination With Sevelamer to Treat to Goal Serum Phosphorus in Patients With End-Stage Kidney Disease on Dialysis (NORMALIZE)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Ardelyx
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Achieving Normal Serum Phosphorus Level
研究概览
简要总结
The study is designed to evaluate the ability of tenapanor alone or in combination with sevelamer to achieve serum phosphorus concentration (sP) within the population reference range (sP >2.5 and ≤4.5 mg/dL) in patients with end-stage renal disease (ESRD) on dialysis with hyperphosphatemia (>4.5 mg/dL).
详细描述
Patients who complete the TEN-02-301 study (PHREEDOM) may be eligible to enroll into TEN-02-401 (NORMALIZE).
Patients from the TEN-02-301 tenapanor arm will either receive only tenapanor or be given sevelamer in addition to tenapanor based on their sP. Patients from the TEN-02-301 sevelamer arm will be given tenapanor in addition to their sevelamer dose and the sevelamer dose will then be adjusted based on their sP following a protocol-specified dose titration schedule. Patients will be monitored for safety and efficacy with in-office and telephone visits for up to an additional 18 months.
Laboratory assessments will be measured at every visit (Weeks 1, 2, 3, 4, 6 and 8 and Months 3, 6, 9, 12, 15 and 18) using a central laboratory.
Safety assessments will be performed during the study and will include physical examinations, vital signs (blood pressure and pulse), body weights, clinical laboratory evaluations, 12-lead electrocardiograms (ECGs), and adverse event (AE) monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must complete TEN-02-301 (PHREEDOM)
排除标准
- •Schedlued for kidney transplant
- •Life expectancy <12 months
研究组 & 干预措施
Tenapanor w/Sevelamer
Tenapanor will be administered QD or BID and sevelamer can be added to achieve desired serum phosphorus level
干预措施: Tenapanor (Drug)
Tenapanor w/Sevelamer
Tenapanor will be administered QD or BID and sevelamer can be added to achieve desired serum phosphorus level
干预措施: Sevelamer Carbonate (Drug)
Sevelamer w/Tenapanor
Sevelamer will be administered QD, BID or TID and tenapanor will be added to achieve desired serum phosphorus level and sevelamer dose will be decreased as needed
干预措施: Tenapanor (Drug)
Sevelamer w/Tenapanor
Sevelamer will be administered QD, BID or TID and tenapanor will be added to achieve desired serum phosphorus level and sevelamer dose will be decreased as needed
干预措施: Sevelamer Carbonate (Drug)
结局指标
主要结局
Achieving Normal Serum Phosphorus Level
时间窗: 18 months
Proportion of patients with serum phosphorus between 2.5 and 4.5 mg/dL
次要结局
- Change in Serum Phosphorus (s-P) From TEN-02-301 (Parent Study) Baseline(up to 2.5 years)
- Change From Baseline in Serum Phosphorus (of Extension Study; TEN-02-401) to Endpoint Visit(up to 18 months)