Chronic Kidney Disease Registry Platform Study
Study Details
Study Description
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.
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Detailed Description
Chronic Kidney Disease (CKD) is characterized by high prevalence, low awareness, poor prognosis, and high medical cost, which seriously jeopardizes human health. The prevalence of CKD among Chinese adults in 2023 is 8.2%. Only 10% of Chinese CKD patients are aware of CKD, and there are many challenges in the diagnosis and treatment of CKD. Therefore, it is of great value to establish a registry platform for the CKD patients' population in China. This registry platform will generate real-world data/evidence on the disease characteristics, diagnosis and treatment patterns, disease progression and clinical outcomes of CKD patients and various subgroups of population, which can improve clinicians' understanding on the current status of patient treatment and treatment outcomes, provide a basis for the formulation of CKD diagnosis and treatment guidelines and policies related to diagnosis and treatment management, and provide a basis for the development strategy of new drugs for CKD, including the selection of target populations, the design of clinical trial protocols, and the screening of clinical sites, and conduce to increasing success rate of CKD drug development.
This is a multicenter, prospective, observational registry platform study that plans to enroll approximately 5,000 Chinese CKD patients in at least 25 study sites, and to establish different CKD subpopulations. During the study duration from 2023 to 2027, we will collect the follow-up data every 6 months in the first year and annually thereafter for CKD patients enrolled in the study. The data includes patients' clinical characteristics, diagnosis and treatment patterns, clinical outcomes, and healthcare resource utilization. Focus on purpose of the study, we will collect data on demographic characteristics, etiology, clinical characteristics, risk factors for disease progression, clinical outcome, and treatment patterns for various CKD subgroups, to establish a CKD registry platform, describe the current status of the diagnosis and treatment of patients with CKD and the gap from the diagnostic and treatment guidelines, explore the risk factors for disease progression and clinical outcome in CKD patients, and construct a risk prediction model for CKD progression and clinical outcome.
Study Design
Outcome Measures
Primary Outcome Measures
- Disease Progression in CKD Patients [From 2023 to 2026]
Patients with progressive deterioration of renal function, including decreased eGFR, rapid progression of CKD
- Clinical Outcomes in CKD Patients - Renal Outcomes [From 2023 to 2026]
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 2026]
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 2026]
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 2026]
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 Albuminuria [From 2023 to 2026]
Changes in UACR, UPCR, and 24 h urine protein (quantitative) from baseline
- Estimates of Changes in Patient Conditions - Changes in eGFR [From 2023 to 2026]
Changes from baseline in glomerular filtration rate (eGFR), eGFR slope
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aged ≥ 18 years at enrollment;
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Patients who meet the diagnostic criteria for CKD;
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Last eGFR ≥ 20 and < 90 mL/min/1.73 m2 (with the CKD-EPI formula) within 12 months prior to enrollment;
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Patients who voluntarily participate in this study and has signed and dated the informed consent form for the study;
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Inclusion criteria for Subpopulation A (CKD patients with albuminuria).
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Last documented albuminuria test within 12 months prior to enrollment indicating UACR ≥ 700 mg/g, or UPCR ≥ 1000 mg/g, or 24 h urine protein (quantitative) ≥ 1 g/24 h.
Exclusion Criteria:
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Patients who have previously undergone/are undergoing/are planning to undergo solid organ transplantation;
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Patients with active malignant tumor requiring drug therapy at the time of screening;
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Women who are pregnant, planning to become pregnant or who are breastfeeding.
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Exclusion criteria for Subpopulation A (CKD patients with albuminuria):
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Patients with NYHA class III or IV heart failure at screening;
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Patients who have had myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), or undergone cardiac surgery, percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), valvular repair/replacement, or received treatment with left ventricular assist device within 3 months prior to screening;
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Patients undergoing renal replacement therapy (RRT) at screening;
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Patients with lupus nephritis (LN), acute progressive glomerulonephritis (RPGN), anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis, autosomal dominant polycystic kidney disease (ADPKD), or Alport syndrome;
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Patients on systemic immunosuppression at screening (inhalation, intranasal administration, or topical steroids are allowed);
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Patients with a life expectancy of less than 1 year, as judged by the investigator;
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Patients who have participated in another interventional clinical trial and have received the investigational drug within 3 months prior to being enrolled.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhongda Hospital. SouthEast University | Nanjing | Jiangsu | China | 210009 |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Principal Investigator: Bicheng Liu, Zhongda Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D1843R00355