Chronic Kidney Diseases
Conditions
Brief summary
This is a multicenter, prospective, observational registry platform study which is designed to establish a CKD registry platform by collecting data on the demographics, etiology and staging, clinical characteristics, diagnostic and treatment patterns, and clinical outcomes of patients with chronic kidney disease (CKD), to describe the current status of the diagnosis and treatment of patients with CKD and the gaps from the diagnostic and treatment guidelines, explore the risk factors for disease progression and clinical outcomes in CKD patients, and construct a risk prediction model for CKD progression and clinical outcomes
Detailed description
Chronic Kidney Disease (CKD) is characterized by its high prevalence, low awareness, poor prognosis, and high medical costs, which seriously jeopardize human health. High-risk factors such as severe proteinuria and uncontrolled hypertension further exacerbate the progression of CKD, leading to adverse kidney outcomes, cardiovascular diseases, hospitalizations, and increased mortality. Given these challenges, establishing a registry platform for high-risk CKD patients in China is essential. This multicenter, prospective, observational registry study aims to comprehensively gather data on the demographic and clinical characteristics, diagnosis and treatment patterns, clinical outcomes, and healthcare resource utilization among high-risk CKD patients in China, which will facilitate the exploration of risk factors associated with CKD progression and clinical outcomes and support the development of predictive models for these outcomes. During the study period from 2023 to 2027, we plan to enroll approximately 5,000 Chinese CKD patients across at least 37 study sites. The study will establish different CKD subpopulations, including but not limited to CKD with High Proteinuria and CKD with Hypertension. Baseline data and annual follow-up data will be collected for the enrolled CKD patients. By establishing this CKD registry platform, we aim to describe the current status of the diagnosis and treatment of CKD patients, identify gaps from diagnostic and treatment guidelines, explore risk factors for disease progression and clinical outcomes, and construct risk prediction models for CKD progression and clinical outcomes.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Registry Platform Study Basic Inclusion \&
Exclusion criteria
Inclusion Criteria: 1. Aged ≥ 18 years at enrollment; 2. Patients who meet the diagnostic criteria for CKD; 3. Last eGFR ≥ 20 and \< 90 mL/min/1.73 m2 (with the CKD-EPI formula) within 12 months prior to enrollment; 4. Patients who voluntarily participate in this study and has signed and dated the informed consent form for the study;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Progression in CKD Patients | From 2023 to 2027 | Patients with progressive deterioration of renal function, including decreased eGFR, rapid progression of CKD |
| Clinical Outcomes in CKD Patients - Renal Outcomes | From 2023 to 2027 | Including renal transplantation, maintenance dialysis, death from renal failure, persistent low eGFR, persistent percent decline in eGFR |
| Clinical Outcomes in CKD Patients - Cardiovascular Outcomes | From 2023 to 2027 | Including acute myocardial infarction, sudden serious arrhythmia, hospitalization due to heart failure, stroke or apoplexy, cardiovascular death |
| Clinical Outcomes in CKD Patients - Cardiac and Renal Composite Outcomes | From 2023 to 2027 | Composite outcome measure consisting of multiple single outcome measures for cardiovascular outcomes and renal outcomes |
| Clinical Outcomes in CKD Patients - All-cause Mortality | From 2023 to 2027 | In-hospital or out-of-hospital deaths from all causes, including but not limited to deaths related to cardiovascular outcomes or renal outcomes, etc. |
| Changes in Patient Conditions - Changes in Proteinuria | From 2023 to 2027 | Changes in UACR, UPCR, and 24 h urine protein (quantitative) from baseline |
| Estimates of Changes in Patient Conditions - Changes in eGFR | From 2023 to 2027 | Changes from baseline in glomerular filtration rate (eGFR), eGFR slope |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORBicheng Liu
Zhongda Hospital
Outcome results
None listed