A Multicenter Real-World Registry of Characteristics, Treatment Strategies, and Clinical Outcomes in Chinese Adults With Chronic Kidney Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- AstraZeneca
- Enrollment
- 3,000
- Locations
- 59
- Primary Endpoint
- Proportion of CKD patients with HP, HF, HTN, and HK at baseline, respectively
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Proportion of CKD patients with HP, HF, HTN, and HK at baseline, respectively
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)