Chronic Kidney Disease
Conditions
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.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of CKD patients with HP, HF, HTN, and HK at baseline, respectively | 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) | 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 | 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 | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical indicators of CKD patients and CKD patients with HP, HF, HTN, or HK | Week 0 to week 96 | To compare the clinical indicators of eGFR slope between CKD patients with or without HP, HF, HTN, HK |
| The HCRU among patients with CKD overall, and in subgroups with HP, HF, HTN, or HK | Week 0 to week 96 | To describe healthcare resource utilization (HCRU) among patients with CKD overall, and in subgroups with HP, HF, HTN, or HK |
| The factors associated with the clinical indicators in patients with CKD overall, and in subgroups | Week 0 to week 96 | To identify the factors associated with the clinical indicators 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 | Week 0 to week 96 | To compare the clinical outcomes of Composite outcome of eGFR decline ≥50% between CKD patients with or without HP, HF, HTN, HK |
| Clinical indicators of CKD patients and CKD patients with HP and HTN | Week 0 to week 96 | To compare the clinical indicators of Change in systolic BP from baseline over time between CKD patients with or without HP, HTN |
| Clinical indicators of CKD patients and CKD patients with HF | Week 0 to week 96 | To compare the clinical indicators of Change of NT-proBNP from baseline over time between CKD patients with or without HF |
| The factors associated with the clinical indicators in patients with CKD overall, and in subgroups of HF | Week 0 to week 96 | To identify the factors associated with the clinical indicator of change of NT-proBNP from baseline over time in patients with CKD overall, and in subgroups with HF |
| 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 | To identify the factors associated with the composite outcome of eGFR decline ≥50% in patients with CKD overall, and in subgroups with HP, HF, HTN, and HK |
| The factors associated with the clinical outcomes in patients with CKD overall, and in subgroups of HK | Week 0 to week 96 | To identify the factors associated with HK outcomes of HK recurrence in patients with CKD overall, and in subgroups with HK |
| Clinical outcomes of CKD patients and CKD patients with HK | Week 0 to week 96 | To compare the clinical outcomes of HK recurrence between CKD patients with or without HK |
Countries
China
Contacts
CONTACTAstraZeneca Clinical Study Information Center
PRINCIPAL_INVESTIGATORXiao Qiang Ding
Zhongshan Hospital Affiliated with Fudan University
Outcome results
None listed