A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of TRC101 in Subjects With Chronic Kidney Disease and Low Serum Bicarbonate Levels
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 5
- 主要终点
- Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE
研究概览
简要总结
This was a double-blind, placebo-controlled, parallel-design, 6-arm, fixed dose study. The study enrolled 135 adult male and female subjects with Stage 3 or 4 chronic kidney disease and low serum bicarbonate levels. The study was conducted in two parts. In Part 1 study drug dosing (TRC101 or placebo) continued for 14 days twice daily (BID). In Part 2 study drug dosing (TRC101 or placebo) continued for 14 days once daily (QD).
The maximum study duration per subject was anticipated to be up to 42 days.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Estimated glomerular filtration rate (eGFR) of 20 to <60 mL/min/1.73m2
- •Serum bicarbonate level of 12 to 20 mEq/L
排除标准
- •Any level of low serum bicarbonate that, in the opinion of the Investigator, requires emergency intervention.
- •Severe comorbid conditions other than chronic kidney disease.
- •Chronic obstructive pulmonary disease.
- •Anticipated changes in doses of any of the following drugs or drug classes: diuretics, non-ophthalmic carbonic anhydrase inhibitors, oral diabetes drugs, antihypertensive drugs, antacids, H2-blockers, or proton pump inhibitors.
- •Excluded drugs or drug classes: insulin, non-daily or "as needed" diuretics, herbal products, dietary supplements, multivitamins, naturopathic remedies, sodium bicarbonate, potassium citrate, sodium citrate or other alkali therapy, non-steroidal anti-inflammatory drugs (NSAIDs), fiber supplements, laxatives, calcium and magnesium supplements, or electrolyte binders and other binder drugs.
研究组 & 干预措施
Placebo-BID
Administered twice daily (BID) for 14 days
干预措施: Placebo (Drug)
TRC101 (1.5g BID)
Administered twice daily (BID) for 14 days
干预措施: TRC101 (Drug)
TRC101 (3g BID)
Administered twice daily (BID) for 14 days
干预措施: TRC101 (Drug)
TRC101 (4.5g BID)
Administered twice daily (BID) for 14 days
干预措施: TRC101 (Drug)
TRC101 (6g QD)
Administered once daily (QD) for 14 days
干预措施: TRC101 (Drug)
Placebo-QD
Administered once daily (QD) for 14 days
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE
时间窗: Through treatment period completion (Day 15)
The number and percentage of subjects who reported treatment-emergent adverse events (TEAEs) summarized by system organ class and preferred term (see Reported Adverse Events) as well as by severity, causality, seriousness, and action taken with regard to study drug. All analyses were descriptive.
Change From Baseline to the End of Treatment (Day 15) in Serum Bicarbonate Within Each Individual TRC101 Dose Group
时间窗: Baseline and Day 15
Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline
次要结局
- Change From Baseline in Serum Bicarbonate at Day 15 Within the Combined TRC101 Treatment Group(Baseline and Day 15)
- Comparison of Change From Baseline in Serum Bicarbonate at Day 15 Between the Combined TRC101 Treatment Group Versus Placebo(Baseline and Day 15)
- Change From Baseline in Serum Bicarbonate at Day 15 Within the TRC101 6g QD Dose Group(Baseline and Day 15)
- Change From Baseline in Serum Bicarbonate at Day 15 Comparison Between the TRC101 6g QD Dose Group Versus Placebo(Baseline and Day 15)
- Change From Baseline in Serum Bicarbonate at Day 15 Comparison Between the TRC101 6g QD Dose Group Versus the TRC101 3g BID Dose Group(Baseline and Day 15)
- Comparison of Change From Baseline in Serum Bicarbonate at Day 15 Between Each TRC101 Dose Group Versus Placebo(Baseline and Day 15)
- Comparison of the Proportion of Subjects Whose Serum Bicarbonate Values Increased From Baseline to Day 15 by Greater Than or Equal to 2, 3, or 4 mEq/L Between Each TRC101 Dose Group Versus Placebo(Baseline and Day 15)
- Comparison of the Proportion of Subjects in the TRC101 6g QD Dose Group Whose Serum Bicarbonate Values Increased From Baseline to Day 15 by Greater Than or Equal to 2, 3, or 4 mEq/L Versus Placebo(Baseline and Day 15)