A Blinded, Placebo-Controlled Extension to Study TRCA-301 to Evaluate the Long-term Safety and Durability of Effect of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 29
- 主要终点
- Incidence of Adverse Events, Serious Adverse Events, and Adverse Events Leading to Withdrawal.
研究概览
简要总结
This study is a 40-week, blinded, placebo-controlled extension of Study TRCA-301 (NCT03317444). Eligible subjects who complete the 12-week treatment period in Study TRCA-301 have the option to participate in this extension study evaluating the long-term safety and durability of effect of TRC101 in subjects with non-dialysis dependent chronic kidney disease and metabolic acidosis. Eligible subjects will be treated with TRC101 or placebo once daily (QD) on an out-patient basis for the subsequent 40 weeks. Subjects will continue to receive the same blinded treatment (TRC101 or placebo) that they received in Study TRCA-301.
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
- Triple (Participant, Care Provider, 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
- •Completed the 12-week treatment period and attended the Week 12 Visit in the parent study TRCA-
- •Blood bicarbonate level of >= 12 mEq/L at the Week 12 Visit in the parent study TRCA-
排除标准
- •Any level of low blood bicarbonate at the Week 12 Visit that, in the opinion of the Investigator, requires emergency intervention or evaluation for an acute acidotic process.
- •Required dialysis for acute kidney injury or worsening CKD during the parent study TRCA-
- •Planned initiation of renal replacement therapy within 6 months following study entry.
- •History or current diagnosis of diabetic gastroparesis, bowel obstruction, swallowing disorders, severe gastrointestinal disorders, inflammatory bowel disease, major gastrointestinal surgery, or active gastric/duodenal ulcers.
- •Serum calcium <= 8.0 mg/dL at the Week 10 in the parent study TRCA-301.
研究组 & 干预措施
TRC101
Administered once daily (QD) for 40 weeks
干预措施: TRC101 (Drug)
Placebo
Administered once daily (QD) for 40 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Adverse Events, Serious Adverse Events, and Adverse Events Leading to Withdrawal.
时间窗: Week 12 Visit in the parent study, TRCA-301, to the Week 54 Visit in the extension study, TRCA-301E.
The incidence of adverse events (AEs), serious adverse events (SAEs) and AEs leading to withdrawal. For incidence of AEs and SAEs, see Adverse Events Section. For incidence of AEs leading to withdrawal, see endpoint values below.
次要结局
- Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range(Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E.)
- Change From Baseline in Serum Bicarbonate at the End of Treatment(Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E.)
- Change From Baseline in the Total Score of the KDQOL-PFD at the End of Treatment(Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E.)
- Change From Baseline in the Duration of Repeated Chair Stand Test at the End of Treatment(Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E.)