A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects With Metabolic Acidosis
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1,480
- 试验地点
- 203
- 主要终点
- Progression of chronic kidney disease
研究概览
简要总结
The purpose of this study is to evaluate the effect of TRC101 on the progression of chronic kidney disease (CKD) and to evaluate the safety profile of TRC101 in CKD patients with metabolic acidosis.
详细描述
This is a randomized, double-blind, placebo-controlled trial. Eligible subjects will be randomized in a 1:1 ratio to TRC101 or placebo. The primary endpoint of the study will be progression of renal disease, defined by time to first occurrence of any event in the composite endpoint consisting of a confirmed ≥ 40% reduction in eGFR, end-stage renal disease (ESRD), and renal death. The study will terminate when the independent blinded Clinical Endpoint Adjudication Committee has positively adjudicated the targeted number of primary efficacy endpoint events. The maximum duration of follow-up for a randomized subject is anticipated to be approximately 6 years.
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
- •Estimated glomerular filtration rate (eGFR) 20 - 40 mL/min/1.73m^
- •Serum bicarbonate 12 - 20 mEq/L.
- •On maximum tolerated dose of ACE inhibitor and/or ARB.
排除标准
- •Acute metabolic acidosis.
- •Anticipated dialysis or kidney transplant within 6 months.
- •Recent acute kidney injury.
研究组 & 干预措施
TRC101
干预措施: TRC101 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Progression of chronic kidney disease
时间窗: Through study completion, up to approximately 6 years.
Time to first occurrence of: a confirmed ≥40% reduction in eGFR; ESRD; renal death.
次要结局
- Death (all-cause), ESRD or a confirmed ≥50% reduction in eGFR(Through study completion, up to approximately 6 years.)
- Cardiovascular death(Through study completion, up to approximately 6 years.)
- ≥40% reduction in eGFR(Through study completion, up to approximately 6 years.)
- Serum creatinine(Through study completion, up to approximately 6 years.)
- ≥50% reduction in eGFR(Through study completion, up to approximately 6 years.)
- Physical functioning (objective)(18 months after randomization.)
- ESRD or renal death(Through study completion, up to approximately 6 years.)
- Primary outcome measure OR cardiovascular death(Through study completion, up to approximately 6 years.)
- Physical functioning (subjective)(18 months after randomization.)
- All-cause hospitalization(Through study completion, up to approximately 6 years.)
- All-cause mortality(Through study completion, up to approximately 6 years.)