Chronic Kidney Disease Registry Platform Study

Chronic Kidney Diseases Clinical Trial

Official title: Chronic Kidney Disease Registry Platform Study

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. Proteinuria is the common clinical symptom of CKD and an independent risk factor to predict the progress of CKD. Proteinuria is closely related to the risk of CKD progression, end-stage kidney disease (ESKD) occurrence and cardiovascular events. CKD with proteinuria has a high prevalence in China. The prevalence gradually increases with the increase of CKD stage. Hypertension is the most common risk factor that accelerates the progression of CKD, increases the risk of cardiovascular disorder and death, and is also the second leading cause of CKD in China. The prevalence of hypertension in CKD patients is higher than that in non-CKD patients. The Chinese CKD population with hypertension has the characteristics of complex etiology, high incidence, low awareness and control rate. How to reasonably diagnose and treat hypertension in CKD patients and improve their prognosis is particularly needed. 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 37 study sites, and to establish different CKD subpopulations (including but not limited to High Proteinuria, Hypertension). During the study duration from 2023 to 2026, we will collect the follow-up data every 12 months 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. ;

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

• NCT number: NCT06117852
• Study type: Observational [Patient Registry]
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center@astrazeneca.com
• Status: Recruiting
• Start date: November 28, 2023
• Completion date: December 31, 2026