2024-520253-21-00招募中3 期
The Chronic Kidney Disease Adaptive Platform Trial Investigating Various Agents for Therapeutic Effect (CAPTIVATE)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 9
- 主要终点
- Chronic eGFR slope estimated from all available eGFR values from week 4 to week 104
研究概览
简要总结
To determine investigational agents or combinations of agents that reduce the rate of eGFR decline (slow progression of CKD), compared to placebo, in patients with chronic kidney disease receiving standard of care therapy.
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
- •Age ≥ 18 years
- •Known chronic kidney disease from any cause (eGFR ≥25 mL/min/1.73m2)
- •Eligible for randomisation in at least one recruiting domain specific appendix
- •Urine albumin-creatinine ratio (uACR) >200 mg/g (22.6 mg/mmol) or urine protein-creatinine ratio (uPCR) >300 mg/g (33.9 mg/mmol) from the most recent result in the previous 3 months
- •On a stable standard of care treatment for CKD, including a SGLT2i unless there is a documented reason not to be using a SGLT2i, for 4 weeks before screening according to treating physician.
- •Treating physician believes finerenone is clinically appropriate for the participant
- •Currently receiving standard of care treatment according to treating physician
- •Participant and treating physician are willing and able to perform trial Core procedures and MRA DSA procedures
- •Provision of written informed consent or eConsent prior to peforming any Core protocol and MRA DSA related procedures
排除标准
- •Currently receiving maintenance dialysis
- •Severe hepatic impairment (defined as Child-Pugh Class C)
- •Adrenal insufficiency
- •Currently pregnant or breast feeding, or intending to become pregnant
- •Planned to commence kidney replacement therapy or kidney transplant surgery in next 6 months
- •Life expectancy less than 6 months
- •Recipient of kidney transplant
- •Hyperkalaemia (serum potassium ≥5.0 mmol/L) at time of screening
- •Current treatment with an mineralocorticoid receptor antagonist, where the treating physician or patient is not willing to discontinue this medication
- •Known allergy, intolerance or contraindication to MRAs
- •Current treatment with strong CYP3A4 inhibitors
- •Systolic BP <110 mmHg or diastolic BP <55 mmHg without antihypertensive therapy at time of screening
结局指标
主要结局
Chronic eGFR slope estimated from all available eGFR values from week 4 to week 104
Chronic eGFR slope estimated from all available eGFR values from week 4 to week 104
次要结局
- Change in albuminuria as measured by uACR (or uPCR if uACR unavailable) between randomisation and 24 weeks, measured as a continuous variable
- Composite outcome of proportion of participants experiencing a ≥40% eGFR decline between randomisation and 108 weeks, and proportion of participants developing kidney failure (defined as eGFR <15 mL/min/1.73m^2 or chronic kidney replacement therapy start) at 108 weeks
- Time to a composite outcome of ≥40% eGFR decline from randomisation or kidney failure
- All-cause mortality at 108 weeks
- Proportion of participants experiencing one or more cardiovascular events (cardiovascular death, hospitalised heart failure, myocardial infarction, stroke) between randomisation and 108 weeks
- Time to first occurrence of a cardiovascular event
- Safety and tolerability of treatment
- Change in quality of life measured using the Quality of Life Impact Survey for Kidney Disease (QDIS-CKD) at 6-monthly intervals from randomisation to week 108
- The Mineralocorticoid Receptor Antagonist Domain-Specific Appendix has a domain-specific secondary outcome of time to the composite of ≥57% eGFR decline or kidney failure
- Change in eGFR from randomisation to end of washout
研究者
Sradha Kotwal
Scientific
The George Institute For Global Health
研究点 (9)
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