2024-518457-42-00招募中2 期
A Phase II randomised, double-blind, parallel-group, multicentre, international trial to investigate the safety and efficacy of vicadrostat and empagliflozin administered with simultaneous vs staggered initiation in participants with chronic kidney disease at risk of kidney disease progression
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.39 个研究点 分布在 8 个国家目标入组 100 人开始时间: 2025年8月4日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 39
- 主要终点
- absolute change in eGFR (mL/min/1.73m2) from baseline to Week 14
研究概览
简要总结
The primary objective is to compare staggered vs simultaneous initiation of vicadrostat in combination with empagliflozin for the absolute change in eGFR from baseline to Week 14.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •At least 18 years old and at least of the legal age of consent in countries where it is greater than 18 years.
- •Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- •Male or female participants. WOCBP must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. For men, birth control is not required during the trial. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information.
- •Evidence of CKD at risk of progression based on two eGFR measurements recorded recently (i.e. within 1 year) and at the time of Visit 1, with each eGFR ≥20 and <60 mL/min/1.73m2, irrespective of UACR. The first of these measurements will be assessed from historical local laboratory results, and the second will be determined from serum creatinine analysed by the central laboratory at Visit 1
- •Treatment with a clinically appropriate, stable dose of either ACEi or ARB (but not both together) for ≥4 weeks before Visit 1, with no planned changes of the therapy for the duration of the trial
排除标准
- •Treatment with an SGLT2i within 4 weeks before Visit
- •Treatment with an SGLT2i should not be interrupted with the intention of enrolment into the trial.
- •Treatment with an MRA, ASi, or potassium-sparing diuretic(s) within 14 days prior to Visit 1, or requiring such treatment before randomisation, or planned during the trial, based on the judgment of the investigator. Treatment with an MRA or ASi should not be interrupted with the intention of enrolment into the trial.
- •Blood potassium of >5.2 mmol/L at Visit
- •Blood ALT or AST >3x ULN at Visit
- •Known severe hepatic impairment (i.e. Child Pugh class C cirrhosis).
- •On dialysis, functioning kidney transplant, or scheduled for transplant.
- •Treated with new immunosuppression therapy for new (or relapse/flare of pre-existing) kidney disease within the last 60 days.
- •Currently treated with systemic mineralocorticoid replacement therapy (e.g. fludrocortisone).
- •Further exclusion criteria apply.
结局指标
主要结局
absolute change in eGFR (mL/min/1.73m2) from baseline to Week 14
absolute change in eGFR (mL/min/1.73m2) from baseline to Week 14
次要结局
- Absolute change in serum potassium (mmol/L) from baseline to Week 12
- Absolute change in eGFR (mL/min/1.73m2) from baseline to Week 12
- Absolute change in SBP (mmHg) from baseline to Week 12
- Relative change (ratio) in UACR from baseline to Week 6
研究者
CT Disclosure & Data Transparency
Scientific
Boehringer Ingelheim International GmbH
研究点 (39)
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