A Multicenter Real-World Registry of Characteristics, Treatment Strategies, and Clinical Outcomes in Chinese Adults With Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 3,000
- 试验地点
- 59
- 主要终点
- Proportion of CKD patients with HP, HF, HTN, and HK at baseline, respectively
研究概览
简要总结
This is a prospective, multicenter, observational registry study designed to collect data to deepen the understanding of CKD therapeutics, changes in clinical practice, cardiorenal risk outcomes and differences in treatment approaches in Chinese CKD patients.
详细描述
To ensure a nationally representative cohort, a total of approximately 3000 participants will be enrolled from around 80 sites strategically selected from various geographic regions in China. The sites will include a mix of top-tier tertiary hospitals, regional medical centers, and representative secondary hospitals to accurately reflect real-world clinical practice at different levels of care. All enrolled participants will be followed up to 96 weeks according to the data collection schedule to assess long-term clinical outcomes. Investigators will obtain an informed consent from participants before screening. The CKD participants will only be considered enrolled in the study after providing written informed consent, followed by the assignment of a unique subject identifier. The data will be collected from medical records by the investigator and entered in a cloud-based electronic case report form (eCRF) using electronic data capture (EDC) system. The EDC system is a software tool designed to ensure quality assurance and facilitate data capture during the study. The data will be extracted from established medical records or other documents of the patients and transcribed to the EDC system.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged ≥18 years.
- •Willing and able to provide written informed consent to participate in the study.
- •Confirmed CKD diagnosis at enrolment, defined by at least one of the following:
- •eGFR <60 mL/min/1.73 m² for ≥3 months, OR
- •Evidence of kidney damage (e.g., UACR ≥30 mg/g or UPCR ≥150 mg/g, structural abnormality on imaging, or kidney biopsy findings consistent with chronic kidney injury) persisting for ≥3 months
排除标准
- •Having a life-threatening comorbidity with life expectancy < 2 years.
- •Severe cardiac disease: life-threatening arrhythmias, or recent MACE (Myocardial infarction (MI), stroke, CV death) within the past 3 months.
- •Pregnant or breastfeeding women.
- •Currently enrolled in any interventional clinical trial or receiving investigational therapy within 3 months of enrollment.
- •Presenting with ESRD, RRT, acute kidney injury (AKI), acute kidney disease (i.e., kidney injury or a decline in renal function persisting for ≤3 months) as a primary disease condition at enrollment.
结局指标
主要结局
Proportion of CKD patients with HP, HF, HTN, and HK at baseline, respectively
时间窗: baseline
To determine the prevalence of HP, HF, HTN, and HK among patients with CKD
Adoption rate of medications (e.g., Endothelin receptor antagonists [ERA], MRA, RASi, SGLT2i)
时间窗: Week 0 to week 96
To describe the treatment patterns in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK
Clinical indicators for CKD patients and CKD patients with HP, HF, HTN, or HK
时间窗: Week 0 to week 96
To describe the clinical indicators of eGFR slope in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK.
Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK
时间窗: Week 0 to week 96
To describe the clinical composite outcome of eGFR decline ≥50% for CKD overall, and in subgroups with HP, HF, HTN, or HK.
Clinical outcomes of CKD patients with HK
时间窗: Week 0 to week 96
To describe HK outcomes of HK recurrence for all CKD patients with HK.
Clinical indicators for CKD patients with HP and HTN
时间窗: Week 0 to week 96
To describe the clinical indicators of Change in systolic BP from baseline over time in patients with CKD and subgroups of HP and HTN.
Clinical indicators for CKD patients with HF
时间窗: Week 0 to week 96
To describe the clinical indicators of Change of NT-proBNP from baseline over time in patients with CKD with HF.
次要结局
- Clinical indicators of CKD patients and CKD patients with HP, HF, HTN, or HK(Week 0 to week 96)
- The HCRU among patients with CKD overall, and in subgroups with HP, HF, HTN, or HK(Week 0 to week 96)
- The factors associated with the clinical indicators in patients with CKD overall, and in subgroups(Week 0 to week 96)
- Clinical outcomes of CKD patients and CKD patients with HP, HF, HTN, or HK(Week 0 to week 96)
- Clinical indicators of CKD patients and CKD patients with HP and HTN(Week 0 to week 96)
- Clinical indicators of CKD patients and CKD patients with HF(Week 0 to week 96)
- The factors associated with the clinical indicators in patients with CKD overall, and in subgroups of HF(Week 0 to week 96)
- The factors associated with the clinical outcomes in patients with CKD overall, and in subgroups of HP, HF, HTN, and HK(Week 0 to week 96)
- The factors associated with the clinical outcomes in patients with CKD overall, and in subgroups of HK(Week 0 to week 96)
- Clinical outcomes of CKD patients and CKD patients with HK(Week 0 to week 96)