A 6-month multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and PK/PD of an age-and body weight-adjusted oral finerenone regimen, in addition to an ACEI or ARB, for the treatment of children, 6 months to 18 years of age, with chronic kidney disease and proteinuria
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 219
- 试验地点
- 3
- 主要终点
- Urinary protein to creatinine ratio reduction of at least THIRTY PERCENT from baseline to day 180 plus or minus 7 days
研究概览
简要总结
Researchers are looking for a better way to treat children who have chronic kidney disease (CKD), which is long-term kidney disease, and proteinuria, a condition in which a person´s kidneys leak protein into the urine.
The study treatment, finerenone, is expected to help control RAAS overactivation together with an ACEI or ARB.
The main purpose of this study is to learn more about whether finerenone added to either ACEI or ARB can help reduce the amount of protein in the participants’ urine more than a placebo. A placebo looks like a treatment but does not have any medicine in it. Participants will also continue to receive their other medications.
The doctors will keep track of any adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 2.00 Month(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants must be 6 months to less than 18 years old at the time when the informed consent/assent is signed.
- •Participants must have a clinical diagnosis of chronic kidney disease CKD at screening Participants must have stable kidney function Treated with an angiotensin-converting enzyme inhibitor ACEI or angiotensin receptor blocker ARB at optimized doses defined as maximally tolerable doses within the recommended dose range according to guidelines on blood pressure management, unchanged for at least 30 days prior to screening.
排除标准
- 未提供
结局指标
主要结局
Urinary protein to creatinine ratio reduction of at least THIRTY PERCENT from baseline to day 180 plus or minus 7 days
时间窗: Urinary protein to creatinine ratio reduction of at least THIRTY PERCENT from baseline to day 180 plus or minus 7 days
次要结局
- Number participants with treatment emergent adverse events(From the start of study intervention (Baseline) to last study intervention plus THREE days up to 190 days)
- Change in serum potassium levels from baseline to day 180 Plus or Minus Seven days(From baseline to day 180 Plus or Minus Seven days)
- Change in eGFR from baseline to day 180 Plus or Minus 7 days(From baseline to day 180 Plus or Minus 7 days)