Zhongshan Hospital Affilicated with Fudan University
Shanghai, China
Location status: Recruiting
NCT Number: NCT07481526
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.
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Observational
Shanghai, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: baseline
To determine the prevalence of HP, HF, HTN, and HK among patients with CKD
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
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.
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.
Time frame: Week 0 to week 96
To describe the clinical composite outcome of End-stage renal disease(ESRD) for all CKD patients and subgroups with HP, HF, HTN, or HK.
Time frame: Week 0 to week 96
To describe the clinical composite outcome of renal death for all CKD patients and subgroups with HP, HF, HTN, or HK.
Time frame: Week 0 to week 96
To describe the clinical composite outcome of CV death for all CKD patients and subgroups with HP, HF, HTN, or HK.
Time frame: Week 0 to week 96
To describe the renal outcome of ≥50% eGFR decline from baseline for all CKD patients and subgroups with HP, HF, HTN, or HK.
Time frame: Week 0 to week 96
To describe the renal outcome of ESRD from baseline for all CKD patients and subgroups with HP, HF, HTN, or HK.
Time frame: Week 0 to week 96
To describe the renal outcome of RRT(renal replacement therapy) from baseline for all CKD patients and subgroups with HP, HF, HTN, or HK.
Time frame: Week 0 to week 96
To describe the renal outcome of CKD stage progression for all CKD patients and subgroups with HP, HF, HTN, or HK.
Time frame: Week 0 to week 96
To describe the renal outcome of Renal-related death for all CKD patients and subgroups with HP, HF, HTN, or HK.
Time frame: Week 0 to week 96
To describe the CV outcome of MACE(major adverse cardiovascular events) for all CKD patients and subgroups with HP, HF, HTN, or HK.
Time frame: Week 0 to week 96
To describe the CV outcome of HF for all CKD patients and subgroups with HP, HF, HTN, or HK.
Time frame: Week 0 to week 96
To describe the CV outcome of CV death (included in the composite of renal or CV death) for all CKD patients and subgroups with HP, HF, HTN, or HK.
Time frame: Week 0 to week 96
To describe all-cause death for all CKD patients and subgroups with HP, HF, HTN, or HK.
Time frame: Week 0 to week 96
To describe all-cause hospitalization for all CKD patients and subgroups with HP, HF, HTN, or HK.
Time frame: Week 0 to week 96
To describe HK outcomes of HK recurrence for all CKD patients with HK.
Time frame: Week 0 to week 96
To describe HK outcomes of Severe HK requiring hospitalisation for all CKD patients with HK.
Time frame: Week 0 to week 96
To describe HK outcomes of Severe HK requiring emergency-department visits for all CKD patients with HK.
Time frame: Week 0 to week 96
To describe the clinical indicators of change in eGFR from baseline over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK.
Time frame: Week 0 to week 96
To describe the clinical indicators of Change in UACR from baseline over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK.
Time frame: Week 0 to week 96
To describe the clinical indicators of Change in UPCR from baseline over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK.
Time frame: Week 0 to week 96
To describe the clinical indicators of Change in UPER from baseline over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK.
Time frame: Week 0 to week 96
To describe the clinical indicators of Proportion of patients achieving UACR <700 mg/g with ≥30% reduction over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK.
Time frame: Week 0 to week 96
To describe the clinical indicators of Proportion of patients achieving UPCR < 1000 mg/g and ≥ 30% reduction from baseline over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK.
Time frame: Week 0 to week 96
To describe the clinical indicators of Proportion of patients achieving UPER <1000 mg/24h with ≥30% reduction over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK.
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.
Time frame: Week 0 to week 96
To describe the clinical indicators of Change in diastolic BP from baseline over time in patients with CKD and subgroups of HP and HTN.
Time frame: Week 0 to week 96
To describe the clinical indicators of Proportion of patients achieving BP control target over time in patients with CKD and subgroups of HP and HTN.
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.
Time frame: Week 0 to week 96
To compare the clinical indicators of eGFR slope between CKD patients with or without HP, HF, HTN, HK
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Week 0 to week 96
To compare the clinical indicators of Change in eGFR from baseline over time between CKD patients with or without HP, HF, HTN, HK
Time frame: Week 0 to week 96
To compare the clinical indicators of change in UACR from baseline over time between CKD patients with or without HP, HF, HTN, HK
Time frame: Week 0 to week 96
To compare the clinical indicators of change in UPCR from baseline over time between CKD patients with or without HP, HF, HTN, HK
Time frame: Week 0 to week 96
To compare the clinical indicators of change in UPER from baseline over time between CKD patients with or without HP, HF, HTN, HK
Time frame: Week 0 to week 96
To compare the clinical indicators of proportion of patients achieving UACR <700 mg/g with ≥30% reduction over time between CKD patients with or without HP, HF, HTN, HK
Time frame: Week 0 to week 96
To compare the clinical indicators of Proportion of patients achieving UPER <1000 mg/24h with ≥30% reduction over time between CKD patients with or without HP, HF, HTN, HK
Time frame: 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
Time frame: Week 0 to week 96
To compare the clinical indicators of change in diastolic BP from baseline over time between CKD patients with or without HP, HTN
Time frame: Week 0 to week 96
To compare the clinical indicators of proportion of patients achieving BP control target over time between CKD patients with or without HP, HTN
Time frame: 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
Time frame: Week 0 to week 96
To identify the factors associated with the clinical indicator of change in eGFR from baseline over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK
Time frame: Week 0 to week 96
To identify the factors associated with the clinical indicator of change in UACR from baseline over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK
Time frame: Week 0 to week 96
To identify the factors associated with the clinical indicator of change in UPCR from baseline over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK
Time frame: Week 0 to week 96
To identify the factors associated with the clinical indicator of change in UPER from baseline over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK
Time frame: Week 0 to week 96
To identify the factors associated with the clinical indicator of proportion of patients achieving UACR <700 mg/g with ≥30% reduction over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK
Time frame: Week 0 to week 96
To identify the factors associated with the clinical indicator of proportion of patients achieving UPCR < 1000 mg/g and ≥ 30% reduction from baseline over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK
Time frame: Week 0 to week 96
To identify the factors associated with the clinical indicator of proportion of patients achieving UPER <1000 mg/24h with ≥30% reduction over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK
Time frame: Week 0 to week 96
To identify the factors associated with the clinical indicator of change in systolic BP from baseline over time in patients with CKD overall, and in subgroups with HP,HTN
Time frame: Week 0 to week 96
To identify the factors associated with the clinical indicator of change in diastolic BP from baseline over time in patients with CKD overall, and in subgroups with HP,HTN
Time frame: Week 0 to week 96
To identify the factors associated with the clinical indicator of Proportion of patients achieving BP control target over time in patients with CKD overall, and in subgroups with HP,HTN
Time frame: 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
Time frame: 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
Time frame: Week 0 to week 96
To identify the factors associated with the composite outcome of ESRD in patients with CKD overall, and in subgroups with HP, HF, HTN, and HK
Time frame: Week 0 to week 96
To identify the factors associated with the composite outcome of renal death in patients with CKD overall, and in subgroups with HP, HF, HTN, and HK
Time frame: Week 0 to week 96
To identify the factors associated with the composite outcome of CV death in patients with CKD overall, and in subgroups with HP, HF, HTN, and HK
Time frame: Week 0 to week 96
To identify the factors associated with the renal outcomes of ≥50% eGFR decline from baseline in patients with CKD overall, and in subgroups with HP,HTN
Time frame: Week 0 to week 96
To identify the factors associated with the renal outcomes of ESRD in patients with CKD overall, and in subgroups with HP, HF, HTN, and HK
Time frame: Week 0 to week 96
To identify the factors associated with the renal outcomes of RRT in patients with CKD overall, and in subgroups with HP, HF, HTN, and HK
Time frame: Week 0 to week 96
To identify the factors associated with the renal outcomes of CKD stage progression in patients with CKD overall, and in subgroups with HP, HF, HTN, and HK
Time frame: Week 0 to week 96
To identify the factors associated with renal-related death in patients with CKD overall, and in subgroups with HP, HF, HTN, and HK
Time frame: Week 0 to week 96
To identify the factors associated with CV outcomes of MACE in patients with CKD overall, and in subgroups with HP, HF, HTN, and HK
Time frame: Week 0 to week 96
To identify the factors associated with CV outcomes of HF in patients with CKD overall, and in subgroups with HP, HF, HTN, and HK
Time frame: Week 0 to week 96
To identify the factors associated with CV outcomes of CV death in patients with CKD overall, and in subgroups with HP, HF, HTN, and HK
Time frame: Week 0 to week 96
To identify the factors associated with CV outcomes of all-cause death in patients with CKD overall, and in subgroups with HP, HF, HTN, and HK
Time frame: Week 0 to week 96
To identify the factors associated with CV outcomes of all-cause hospitalization in patients with CKD overall, and in subgroups with HP, HF, HTN, and HK
Time frame: 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
Time frame: Week 0 to week 96
To identify the factors associated with HK outcomes of severe HK requiring hospitalisation in patients with CKD overall, and in subgroups with HK
Time frame: Week 0 to week 96
To identify the factors associated with HK outcomes of severe HK requiring emergency-department visits in patients with CKD overall, and in subgroups with HK
Time frame: Week 0 to week 96
To compare the clinical outcomes of composite outcome of ESRD between CKD patients with or without HP, HF, HTN, HK
Time frame: Week 0 to week 96
To compare the clinical outcomes of composite outcome of renal death between CKD patients with or without HP, HF, HTN, HK
Time frame: Week 0 to week 96
To compare the clinical outcomes of composite outcome of CV death between CKD patients with or without HP, HF, HTN, HK
Time frame: Week 0 to week 96
To compare the clinical outcomes of Renal outcomes of ≥50% eGFR decline from baseline between CKD patients with or without HP, HF, HTN, HK
Time frame: Week 0 to week 96
To compare the clinical outcomes of Renal outcomes of ESRD between CKD patients with or without HP, HF, HTN, HK
Time frame: Week 0 to week 96
To compare the clinical outcomes of Renal outcomes of RRT between CKD patients with or without HP, HF, HTN, HK
Time frame: Week 0 to week 96
To compare the clinical outcomes of CKD stage progression between CKD patients with or without HP, HF, HTN, HK
Time frame: Week 0 to week 96
To compare the clinical outcomes of Renal-related death between CKD patients with or without HP, HF, HTN, HK
Time frame: Week 0 to week 96
To compare the clinical outcomes of CV outcomes of MACE between CKD patients with or without HP, HF, HTN, HK
Time frame: Week 0 to week 96
To compare the clinical outcomes of CV outcomes of hHF between CKD patients with or without HP, HF, HTN, HK
Time frame: Week 0 to week 96
To compare the clinical outcomes of All-cause death between CKD patients with or without HP, HF, HTN, HK
Time frame: Week 0 to week 96
To compare the clinical outcomes of All-cause hospitalization between CKD patients with or without HP, HF, HTN, HK
Time frame: Week 0 to week 96
To compare the clinical outcomes of HK recurrence between CKD patients with or without HK
Time frame: Week 0 to week 96
To compare the clinical outcomes of Severe HK requiring hospitalisation between CKD patients with or without HK
Time frame: Week 0 to week 96
To compare the clinical outcomes of Severe HK requiring emergency-department visits between CKD patients with or without HK
Time frame: Week 0 to week 96
To compare the clinical indicators of proportion of patients achieving UPCR < 1000 mg/g and ≥ 30% reduction from baseline over time between CKD patients with or without HP, HF, HTN, HK
Time frame: Week 0 to week 96
To identify the factors associated with All-cause death in patients with CKD overall, and in subgroups with HP, HF, HTN, and HK
Time frame: Week 0 to week 96
To identify the factors associated with all-cause hospitalization in patients with CKD overall, and in subgroups with HP, HF, HTN, and HK
Time frame: Week 0 to week 96
To compare the clinical indicators of eGFR slope under different treatment in CKD patients and CKD patients with HP, HF, HTN or HK
Time frame: Week 0 to week 96
To compare the HCRU in CKD patients with or without HP, HF, HTN or HK
Time frame: Week 0 to week 96
To compare the HCRU under different treatment in CKD patients with HP, HF, HTN or HK
Time frame: Week 0 to week 96
To compare the composite outcome of eGFR decline ≥50% between CKD patients managed in nephrology clinics and non-nephrology clinics , if available
Time frame: Week 0 to week 96
To compare the composite outcome of eGFR decline ≥50% under different treatment in CKD patients and CKD patients with HP, HF, HTN or HK
Time frame: Week 0 to week 96
To compare the clinical indicators of change in eGFR from baseline over time under different treatment in CKD patients and CKD patients with HP, HF, HTN or HK
Time frame: Week 0 to week 96
To compare the clinical indicators of change in UACR from baseline over time under different treatment in CKD patients and CKD patients with HP, HF, HTN or HK
Time frame: Week 0 to week 96
To compare the clinical indicators of change in UPCR from baseline over time under different treatment in CKD patients and CKD patients with HP, HF, HTN or HK
Time frame: Week 0 to week 96
To compare the clinical indicators of proportion of patients achieving UACR <700 mg/g with ≥30% reduction over time under different treatment in CKD patients and CKD patients with HP, HF, HTN or HK
Time frame: Week 0 to week 96
To compare the clinical indicators of proportion of patients achieving UPCR < 1000 mg/g and ≥ 30% reduction from baseline over time under different treatment in CKD patients and CKD patients with HP, HF, HTN or HK
Time frame: Week 0 to week 96
To compare the clinical indicators of proportion of patients achieving UPER <1000 mg/24h with ≥30% reduction over time under different treatment in CKD patients and CKD patients with HP, HF, HTN or HK
Time frame: Week 0 to week 96
To compare the clinical indicators of change in systolic BP from baseline over time under different treatment in CKD patients and CKD patients with HP, HTN
Time frame: Week 0 to week 96
To compare the clinical indicators of change in diastolic BP from baseline over time under different treatment in CKD patients and CKD patients with HP, HTN
Time frame: Week 0 to week 96
To compare the clinical indicators of proportion of patients achieving BP control target over time under different treatment in CKD patients and CKD patients with HP, HTN
Time frame: Week 0 to week 96
To compare the clinical indicators of change of NT-proBNP from baseline over time under different treatment in CKD patients and CKD patients with HF
Time frame: Week 0 to week 96
To compare the composite outcome of ESRD under different treatment in CKD patients and CKD patients with HP, HF, HTN or HK
Time frame: Week 0 to week 96
To compare the composite outcome of RRT under different treatment in CKD patients and CKD patients with HP, HF, HTN or HK
Time frame: Week 0 to week 96
To compare the composite outcome of CKD stage progression under different treatment in CKD patients and CKD patients with HP, HF, HTN or HK
Time frame: Week 0 to week 96
To compare the composite outcome of Renal-related death under different treatment in CKD patients and CKD patients with HP, HF, HTN or HK
Time frame: Week 0 to week 96
To compare the CV outcomes of MACE under different treatment in CKD patients and CKD patients with HP, HF, HTN or HK
Time frame: Week 0 to week 96
To compare the CV outcomes of hHF under different treatment in CKD patients and CKD patients with HP, HF, HTN or HK
Time frame: Week 0 to week 96
To compare the CV outcomes of CV death under different treatment in CKD patients and CKD patients with HP, HF, HTN or HK
Time frame: Week 0 to week 96
To compare All-cause death under different treatment in CKD patients and CKD patients with HP, HF, HTN or HK
Time frame: Week 0 to week 96
To compare All-cause hospitalization under different treatment in CKD patients and CKD patients with HP, HF, HTN or HK
Time frame: Week 0 to week 96
To compare HK recurrence under different treatment in CKD patients and CKD patients with HK
Time frame: Week 0 to week 96
To compare the composite outcome of ESRD between CKD patients managed in nephrology clinics and non-nephrology clinics , if available
Time frame: Week 0 to week 96
To compare the composite outcome of renal death between CKD patients managed in nephrology clinics and non-nephrology clinics , if available
Time frame: Week 0 to week 96
To compare the composite outcome of CV death between CKD patients managed in nephrology clinics and non-nephrology clinics , if available
Time frame: Week 0 to week 96
To compare the renal outcomes of ≥50% eGFR decline from baseline between CKD patients managed in nephrology clinics and non-nephrology clinics , if available
Time frame: Week 0 to week 96
To compare the renal outcomes of ESRD between CKD patients managed in nephrology clinics and non-nephrology clinics , if available
Time frame: Week 0 to week 96
To compare the renal outcomes of RRT between CKD patients managed in nephrology clinics and non-nephrology clinics , if available
Time frame: Week 0 to week 96
To compare the renal outcomes of CKD stage progression between CKD patients managed in nephrology clinics and non-nephrology clinics , if available
Time frame: Week 0 to week 96
To compare the renal outcomes of Renal-related death between CKD patients managed in nephrology clinics and non-nephrology clinics , if available
Time frame: Week 0 to week 96
To compare the CV outcomes of MACE between CKD patients managed in nephrology clinics and non-nephrology clinics , if available
Time frame: Week 0 to week 96
To compare the CV outcomes of hHF between CKD patients managed in nephrology clinics and non-nephrology clinics , if available
Time frame: Week 0 to week 96
To compare the CV outcomes of CV death between CKD patients managed in nephrology clinics and non-nephrology clinics , if available
Time frame: Week 0 to week 96
To compare the All-cause death between CKD patients managed in nephrology clinics and non-nephrology clinics , if available
Time frame: Week 0 to week 96
To compare the All-cause hospitalization between CKD patients managed in nephrology clinics and non-nephrology clinics , if available
Contact information is provided by the study sponsor or research team.
AstraZeneca
Industry
A Multicenter Real-World Registry of Characteristics, Treatment Strategies, and Clinical Outcomes in Chinese Adults With Chronic Kidney Disease
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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