A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety 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
- 217
- 试验地点
- 44
- 主要终点
- Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range
研究概览
简要总结
This is a multicenter, double-blind, placebo-controlled, parallel-design study. The study will enroll approximately 210 adult male and female subjects with stage 3 or 4 chronic kidney disease and metabolic acidosis. The study dosing (TRC101 or placebo) will continue for 12 weeks once daily.
The maximum study duration is anticipated to be up to 16 weeks.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Blood bicarbonate level of 12 to 20 mEq/L.
- •Estimated glomerular filtration rate (eGFR) of 20 to 40 mL/min/1.73m
- •Stable kidney function defined as <=20% variability in eGFR during screening period.
排除标准
- •Any level of low blood bicarbonate during the screening period that in the opinion of the Investigator, requires emergency intervention or evaluation for an acute acidotic process.
- •Anuria, dialysis, acute kidney injury, or history of acute kidney insufficiency within 3 months prior to screening.
- •Heart failure with maximum New York Heart Association (NYHA) Class IV symptoms or that required hospitalization during the preceding 6 months.
- •Heart or kidney transplant.
- •Chronic obstructive pulmonary disease (COPD) that is treated with chronic oral steroids, that requires the subject to be on oxygen, or that required hospitalization within the previous 6 months.
- •Change in doses to alkali therapy in the 4 weeks prior to screening.
- •History or current diagnosis of diabetic gastroparesis, bowel obstruction, swallowing disorders, inflammatory bowel disease, major gastrointestinal surgery, frequent diarrhea or active gastric/duodenal ulcers.
- •Serum calcium <= 8.0 mg/dL at screening.
- •Planned initiation of renal replacement therapy within 12 weeks following randomization.
- •Use of polymeric binder drugs within 14 days prior to screening.
研究组 & 干预措施
TRC101
Administered once daily (QD) for 12 weeks
干预措施: TRC101 (Drug)
Placebo
Administered once daily (QD) for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range
时间窗: Baseline to Week 12
Composite endpoint of the percentage of subjects having a change from baseline in serum bicarbonate ≥ 4 mEq/L or having serum bicarbonate in the normal range (22 - 29 mEq/L) at the end of treatment (Week 12 Visit).
次要结局
- Change From Baseline to End of Treatment in Serum Bicarbonate(Baseline to Week 12)