A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Parallel Design Study to Evaluate the Pharmacodynamics, Safety, and Tolerability of AZD1722 in End-Stage Renal Disease Patients on Hemodialysis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Ardelyx
- 入组人数
- 88
- 试验地点
- 3
- 主要终点
- Change in Mean Weekly Interdialytic Weight Gain (IDWG)
研究概览
简要总结
The purpose of this study is to determine if the study drug is safe, tolerable and active in reducing fluid overload/weight gain between dialysis sessions for patients with End Stage Renal Disease on Hemodialysis.
详细描述
This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacodynamics of the study drug in male and female patients with end-stage renal disease on hemodialysis. The study consists of a 2 week treatment-free run-in period where entry criteria are verified, a 4-week treatment period, of which the first week of treatment will be performed as an in-patient study in a clinical pharmacology unit (CPU) and the remaining three weeks of treatment will performed as an out-patient study, and a 2-week treatment-free follow-up period.
Safety assessments will be performed at regular intervals and will include clinical and vital signs, clinical laboratory evaluations, ECGs, and AE monitoring. Pharmacodynamic assessments will include, but are not limited to, interdialytic weight gain (IDWG), blood pressure, and stool sodium excretion. Pharmacokinetic assessments will include blood sampling for measurement of study drug plasma concentrations.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged 18 to 80 years, inclusive;
- •Body mass index between 18 and 45 kg/m2, inclusive;
- •Ambulatory (≥ 6 months) maintenance hemodialysis;
- •Stable dialysis treatment regimen 3x/week for ≥ 2 months prior to screening visit.
排除标准
- •Currently taking diuretic medication;
- •Has a urine production of ≥ 200 ml/day (based on a 24-hour measurement starting on Day -1 and completed prior to randomization);
- •Predialysis systolic BP >200 mmHg or diastolic BP >110 mmHg on two successive occasions during the 2-week run-in period;
- •Predialysis SBP < 110 mmHg on two successive occasions during the 2-week run-in period
研究组 & 干预措施
AZD1722- in patient
Tenapanor administered in a clinical pharmacology unit
干预措施: AZD1722 (in-patient) (Drug)
Placebo- in patient
Placebo (size and color matched to experimental drug) administered in a clinical pharmacology unit
干预措施: Placebo (in-patient) (Drug)
AZD1722 out-patient
Tenapanor
干预措施: AZD1722 (out-patient) (Drug)
Placebo out-patient
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Mean Weekly Interdialytic Weight Gain (IDWG)
时间窗: Run-in period (Weeks -2 and -1) versus Week 4 (end of treatment)
Patients are weighed pre dialysis prior to their first dialysis of the week. This measure looks at the change in pre-dialysis weight over time
次要结局
- Stool Sodium Content(Days 1 through 7)