NCT07753993招募中3 期
A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Renal Outcomes and Mortality in Participants With Chronic Kidney Disease (Elevate-CKD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 7,000
- 试验地点
- 715
- 主要终点
- To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the composite of ≥ 50% sustained decline in eGFR, ESKD, or all-cause mortality
研究概览
简要总结
This is a Phase III, randomized, double-blind, parallel-group, placebo-controlled multicenter study to investigate outcomes with elecoglipron compared with placebo in participants with CKD with and without T2DM who are on background SGLT2i (dapagliflozin) as GDMT and other SoC treatments for CKD.
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)
盲法说明
Placebo controlled
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with confirmed CKD; UACR ≥30 mg/g and eGFR ≥20 mL/min/1.73 m² within specified ranges.
- •On stable, patient maximum tolerated, labeled daily dose of ACEI or ARB for ≥4 weeks at least 28 days before screening.
排除标准
- •BMI <23 kg/m² at screening
- •History of type 1 diabetes mellitus
- •HbA1c ≥10% (86 mmol/mol) at screening
- •Currently receiving, or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema.
- •Have had more than one episode of severe hypoglycemia within 180 days prior to screening, or hypoglycemia unawareness
- •Acute coronary syndrome, major cardiac procedure, stroke, or TIA within 3 months prior to screening
- •Clinically significant condition affecting the upper GI tract or chronic use of any medication that affects gastric motility or gastric emptying
- •History of acute or chronic pancreatitis
- •History/family history (first degree) of medullary thyroid cancer or MEN2
研究组 & 干预措施
Placebo
Active Comparator
Placebo matching Elecoglipron tablet once daily
干预措施: Placebo (Drug)
Elecoglipron
Experimental
Elecoglipron tablet once daily
干预措施: Elecoglipron (Drug)
结局指标
主要结局
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the composite of ≥ 50% sustained decline in eGFR, ESKD, or all-cause mortality
时间窗: Event-driven, trial is estimated to be up to 4.5 years
Time to the first occurrence of any component of this composite: * ≥ 50% sustained decline in eGFR * ESKD defined as sustained eGFR \< 10 mL/min/1.73 m2, or Chronic dialysis treatment, or Receiving a renal transplant * All-cause mortality
次要结局
- To evaluate the effect of elecoglipron compared with placebo in reducing the risk of composite of all-cause mortality, MI, or stroke(Event-driven, trial is estimated to be up to 4.5 years)
- To evaluate the effect of elecoglipron compared with placebo in reducing the risk of MACE (CV death, MI, or stroke)(Event-driven, trial is estimated to be up to 4.5 years)
- To evaluate the effect of elecoglipron compared with placebo in reducing the risk of all-cause mortality(Event-driven, trial is estimated to be up to 4.5 years)
- To evaluate the effect of elecoglipron compared with placebo in reducing the risk of CV death(Event-driven, trial is estimated to be up to 4.5 years)
- To evaluate the effect of elecoglipron compared with placebo in reducing the risk of CV death or HF hospitalizations(Event-driven, trial is estimated to be up to 4.5 years)
- To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the composite endpoint of CV death, MI, stroke, or HF hospitalizations(Event-driven, trial is estimated to be up to 4.5 years)
- To evaluate the effect of elecoglipron compared with placebo in reducing the risk of all-cause hospitalization(Event-driven, trial is estimated to be up to 4.5 years)
- To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the composite of ≥ 50% sustained decline in eGFR, ESKD, or CV and renal death(Event-driven, trial is estimated to be up to 4.5 years)
- To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the pure renal composite of ≥ 50% sustained decline in eGFR, ESKD, or renal death(Event-driven, trial is estimated to be up to 4.5 years)
研究者
研究点 (715)
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