The Chronic Kidney Disease Adaptive Platform Trial Investigating Various Agents for Therapeutic Effect
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 32
- 主要终点
- eGFR slope
研究概览
简要总结
CAPTIVATE is an international, multi-centre, Phase III, adaptive, platform, randomised controlled trial in people with chronic kidney disease (CKD).
CAPTIVATE aims to find the best treatment, or combination of treatments, that slow the progression of CKD so that fewer people develop kidney failure.
CAPTIVATE provides a research platform that allows many treatment-related questions to be answered within a common trial set-up.
详细描述
Chronic kidney disease (CKD) affects over 800 million people globally and is projected to be the 5th most common cause of death by 2040. CKD progresses to kidney failure, increases the risk of early death, heart disease, and leads to a poorer quality of life.
Current treatments do not entirely remove the risk of kidney failure in people with CKD. To improve the outcomes of people with CKD, it is crucial to find the best treatment or combination of treatments that can slow CKD progression. CAPTIVATE aims to address this need.
CAPTIVATE has been designed to test multiple treatments within a common research platform. This design is more efficient and will lead to a shorter time for patients to receive effective treatments. The trial is 'eternal', which means that participants will continue to be recruited for many years until the trial is finally wound up. It is also 'adaptive', providing the flexibility to add new treatments, or remove those that are not working.
Participants can participate in more than one treatment at the same time or at different times. Participants receive each study treatment for 2 years. For each treatment, participants are followed up at study visits that occur at approximately one month, 3 months, 6 months, 12 months, 18 months and 2 years after starting treatment. A final study visit occurs one month after the end of the 2-year treatment phase. Information collected at study visits include blood and urine test results, safety assessments and treatment adherence. Information about the overall health status of each participant is collected every 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The default position within CAPTIVATE is that treatment allocations determined by randomisation will be provided on a blinded basis. Blinding, however, may not always be feasible particularly for behavioural or device-related interventions.
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
- •Age ≥ 18 years
- •Known chronic kidney disease from any cause (eGFR ≥25 mL/min/1.73m2)
- •Currently receiving standard of care treatment according to treating physician
- •Eligible for randomisation in at least one recruiting domain-specific appendix
- •Participant and treating physician are willing and able to perform trial procedures
排除标准
- •Planned to commence kidney replacement therapy or kidney transplant surgery in next 6 months
- •Life expectancy less than 6 months
研究组 & 干预措施
Finerenone
Finerenone 10mg or 20mg tablets
干预措施: Finerenone (Drug)
Placebo Finerenone
Finerenone matched placebo tablets
干预措施: Placebo Finerenone (Drug)
结局指标
主要结局
eGFR slope
时间窗: From randomisation to week 108
eGFR slope calculated using eGFR values from randomisation to week 108
次要结局
- Change in albuminuria(From randomisation to week 24)
- Composite of 40% eGFR decline or kidney failure(From randomisation to week 108)
- All-cause mortality at 108 weeks(108 weeks)
- Number of cardiovascular events(108 weeks)
- Safety and tolerability of treatment(108 weeks)
- Change in quality of life(From randomisation to week 108)