A Prospecitve Multicenter, Observational Registry Study
ConditionChronic Kidney Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAstraZeneca
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female patients aged ≥18 years.
Willing and able to provide written informed consent to participate in the study.
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
Disqualifiers
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.
Trial population
Adult CKD patients who meet the eligibility criteria
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Proportion of CKD patients with HP, HF, HTN, and HK at baseline, respectively
To determine the prevalence of HP, HF, HTN, and HK among patients with CKD
Time frame
baseline2
Adoption rate of medications (e.g., Endothelin receptor antagonists [ERA], MRA, RASi, SGLT2i)
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 963
Clinical indicators for CKD patients and CKD patients with HP, HF, HTN, or HK
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 964
Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK
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 96Secondary outcomes
1
Clinical indicators of CKD patients and CKD patients with HP, HF, HTN, or HK
To compare the clinical indicators of eGFR slope between CKD patients with or without HP, HF, HTN, HK
Time frame
Week 0 to week 962
The HCRU among patients with CKD overall, and in subgroups with HP, HF, HTN, or HK
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 963
The factors associated with the clinical indicators in patients with CKD overall, and in subgroups
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 964
Clinical outcomes of CKD patients and CKD patients with HP, HF, HTN, or HK
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 96Other outcomes
1
Clinical indicators of CKD patients and CKD patients with HP, HF, HTN, or HK
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 962
The HCRU among patients with CKD overall, and in subgroups
To compare the HCRU in CKD patients with or without HP, HF, HTN or HK
Time frame
Week 0 to week 963
The HCRU among patients with CKD overall, and in subgroups
To compare the HCRU under different treatment in CKD patients with HP, HF, HTN or HK
Time frame
Week 0 to week 964
Clinical outcomes of CKD patients in nephrology clinics and non-nephrology clinics
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 96Sponsors and contacts
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Source ClinicalTrials.gov