The chronic kidney disease adaptive platform trial investigating various agents for therapeutic effects
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 27
- 主要终点
- eGFR slope
研究概览
简要总结
Multi-centre, multi-arm, Phase III, placebo-controlled, parallel group, adaptive platform randomised controlled trial in patients with CKD. Participants in CAPTIVATE will be actively followed up for 108 weeks post-randomisation, and passively followed up until death. The primary outcome of eGFR slope will be calculated using values obtained from randomisation to week 108. A pipeline of various therapeutic agents to be studied in the future will be added as domain-specific appendices (DSAs) under the overarching core protocol. Interventions will be evaluated in participants receiving standard of care therapy. DSAs will be implemented in accordance with the core protocol, however, they may have additional characteristics or design features that will be described in the relevant DSA. Participants will be able to participate concurrently and also sequentially in more than one DSA, provided that they meet DSA eligibility criteria. CAPTIVATE is intended to be perpetual and will continue to operate until there are no open DSAs, and no participants in follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Core Inclusion Criteria
- •Age ≥ 18 years
- •Known CKD from any cause (eGFR ≥25 mL/min/1.73m2)
- •Eligible for randomisation in at least one recruiting domain-specific appendix MRA Domain Specific Inclusion Criteria
- •On stable CKD treatment, including SGLT2i unless contraindicated, for 4 weeks pre-screening per physician.
- •uACR greater than 200mg/g or uPCR greater than 300mg/g.
排除标准
- •Core Exclusion Criteria
- •Currently receiving maintenance dialysis
- •Planned to commence kidney replacement therapy or kidney transplant surgery in next 6 months
- •Life expectancy less than 6 months MRA Domain Exclusion Criteria
- •Recipient of kidney transplant
- •Current treatment with MRA
- •Known allergies to MRAs
- •Treatment with strong CYP3A4 inhibitors
- •SBP less than 110mmHg or DBP less than 55mmHg without antihypertensive therapy
- •Severe hepatic impairment
- •Adrenal insufficiency
- •Currently pregnant or breastfeeding, or intending to become pregnant.
结局指标
主要结局
eGFR slope
时间窗: Week 108
次要结局
- Change in albuminuria measured as uACR(Week 24)
- Composite outcome of proportion of participants experiencing a 40% eGFR decline and proportion of participants experiencing kidney failure(Week 108)
- Time to composite outcome of more than 40% eGFR decline(First occurence)
- All-cause mortality(Week 108)
- Proportion of participants experiencing cardiovascular events(Week 108)
- Time to first occurence of CV event(First occurence)
- Change in quality of life(Week 108)
研究者
Vivekanand Jha
George Institute Services India Pvt Ltd