A Phase 2b, Randomized, Double Blind, Placebo-controlled, Parallel Group, Multicentre Dose Finding Study to Evaluate the Efficacy, Safety and Tolerability of AZD1722 to Treat Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Ardelyx
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Change in Serum Phosphate Levels
研究概览
简要总结
Randomized. double blind, placebo controlled, parallel arms dose finding study with a 4 weeks treatment period
详细描述
The study consists of a screening period of approximately 1 week, a wash out period of up to 3 weeks, where existing phosphate lowering medication is withheld, a 4-week treatment period and a follow-up period of up to 2 weeks, during which patients are put back on their pre washout phosphate lowering medication.
The wash out period will be either 1 week, 2 weeks or 3 weeks depending on the increase in s-phosphate levels.
There are 7 parallel treatment arms in the study with bid and od treatment regimens.
Laboratory efficacy endpoints and safety assessments will be evaluated at various times throughout the study.
The target population of the study is: male or female patients, above18 years of age with End Stage Renal Disease (ESRD) on chronic maintenance hemodialysis (HD) 3 times a week for a minimum of 3 months.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Females and males aged ≥18 years
- •Chronic maintenance hemodialysis 3 x/week for a at least 3 months
- •Prescribed and taking at least 3 doses of phosphate binder per day
- •Serum phosphate levels should be between 3.5 and 8.0 mg/dL ; 1.13 mmol/L and 2.58 mmol/L (inclusive) at screening
- •Total serum calcium levels 2.0 - 2.6 mmol/L inclusive at screening
- •For randomization in the study, after up to 3 weeks wash out of phosphate binders, patients must have serum phosphate levels of at least
- •0 mg/dL (1.94 mmol/L) but below 10 mg/dL (3.23 mmol/L) and have had an increase of at least 1.5 mg/dL (0.48 mmol/L) vs pre wash out
排除标准
- •Severe hyperphosphatemia defined as >10 mg/dL on Phosphate-binders at all time points during clinical routine monitoring for the 3 preceding months before screening visit.
- •Serum parathyroid hormone >1200 pg/mL
- •Significant metabolic acidosis
- •Clinical signs of hypovolemia at randomization
研究组 & 干预措施
30 mg od
30 mg AZD1722 od
干预措施: AZD1722 (Drug)
1 mg bid
1 mg AZD1722 bid
干预措施: AZD1722 (Drug)
3 mg bid
3 mg AZD1722 bid
干预措施: AZD1722 (Drug)
10 mg bid
10 mg AZD1722 bid
干预措施: AZD1722 (Drug)
30 mg bid
30 mg AZD1722 bid
干预措施: AZD1722 (Drug)
3 mg od
3 mg AZD1722 od
干预措施: AZD1722 (Drug)
Placebo
Placebo (double dummy technique)
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Serum Phosphate Levels
时间窗: End of wash out (pre randomization value) to end of treatment (Day 29)
Change in serum phosphate levels from the end of wash out (pre randomization value) to end of treatment
次要结局
- Change From Baseline in Calcium x Phosphorus Product(End of wash out (pre randomization value) to end of treatment (Day 29))