Chronic Kidney Disease Registry Platform Study

AstraZeneca34 个研究点分布在 1 个国家目标入组 1,927 人2023年11月28日

适应症Chronic Kidney Diseases

概览

阶段: 不适用
干预措施: Group A
疾病 / 适应症: Chronic Kidney Diseases
发起方: AstraZeneca
入组人数: 1927
试验地点: 34
主要终点: Disease Progression in CKD Patients
状态: 进行中（未招募）
最后更新: 上个月

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

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

详细描述

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.

注册库

clinicaltrials.gov

开始日期

2023年11月28日

结束日期

2028年11月30日

最后更新

上个月

研究类型

Observational

性别

All

研究者

发起方

AstraZeneca

责任方

Sponsor

入排标准

入选标准

•Registry Platform Study Basic Inclusion \&

排除标准

•Inclusion Criteria:
•Aged ≥ 18 years at enrollment;
•Patients who meet the diagnostic criteria for CKD;
•Last eGFR ≥ 20 and \< 90 mL/min/1.73 m2 (with the CKD-EPI formula) within 12 months prior to enrollment;
•Patients who voluntarily participate in this study and has signed and dated the informed consent form for the study;
•Exclusion Criteria:
•Patients who have previously undergone/are undergoing/are planning to undergo solid organ transplantation;
•Patients with active malignant tumor requiring drug therapy at the time of screening;
•Women who are pregnant, planning to become pregnant or who are breastfeeding.
•Group A (Participants with CKD and High Proteinuria) Inclusion \& Exclusion Criteria: