Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
5000 participants
OBSERVATIONAL
2023-11-28
2028-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A
Participants with CKD and High Proteinuria
No interventions assigned to this group
Group B
Participants with CKD and Hypertension
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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;
Last documented proteinuria 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.
1. Last documented test within 12 months prior to enrollment indicating UACR\>200 mg/g（22.6 mg/mmol）and \<5000 mg/g（565 mg/mmol）, or UPCR \>500 mg/g and \<8000 mg/g, or 24 h urine protein (quantitative) \>0.5 g/24 h and \<8 g/24 h;
2. Patients with hypertension history and Systolic Blood Pressure ≥130 mmHg at screening;
Exclusion Criteria
2. Patients with active malignant tumor requiring drug therapy at the time of screening;
3. Women who are pregnant, planning to become pregnant or who are breastfeeding.
1. Patients with NYHA class III or IV heart failure at screening;
2. 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;
3. Patients undergoing renal replacement therapy (RRT) at screening;
4. Patients on systemic immunosuppression at screening (inhalation, intranasal administration, or topical steroids are allowed) except for stable maintenance therapy. The stable maintenance therapy means treatment at least 3 months with Prednisone 10mg/day or lower (or equivalent dose of other drugs), Azathioprine 100mg/day or lower, or Mycophenolate mofetil 1000mg/day or lower (or equivalent dose of other drugs);
5. Patients with a life expectancy of less than 1 year, as judged by the investigator;
6. Patients who have participated in another interventional clinical trial and have received the investigational drug within 1 month prior to being enrolled.
1. Patients with NYHA class IV heart failure at screening;
2. Patients who have had stroke, transient ischemic attack (TIA), Carotid artery surgery or carotid angioplasty and stenting, acute Coronary Syndrome, or hospitalization caused by heart failure deterioration within 3 months prior to screening;
3. Patients who have known severe hepatic injury (defined as Child-Pugh class C) based on medical history;
4. Patients undergoing renal replacement therapy (RRT) within 12 weeks prior to screening;
5. Patients on systemic immunosuppression prior to screening (inhalation, intranasal administration, or topical steroids are allowed) except for stable maintenance therapy at least 3 months;
6. Patients with a life expectancy of less than 1 year, as judged by the investigator;
7. Patients who have participated in another interventional clinical trial and have received the investigational drug within 1 months prior to being enrolled.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bicheng Liu
Role: PRINCIPAL_INVESTIGATOR
Zhongda Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Baotou, , China
Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Changsha, , China
Research Site
Changsha, , China
Research Site
Changzhou, , China
Research Site
Chengdu, , China
Research Site
Chengdu, , China
Research Site
Chongqing, , China
Research Site
Dongguan, , China
Research Site
Guangzhou, , China
Research Site
Guangzhou, , China
Research Site
Haikou, , China
Research Site
Hefei, , China
Research Site
Hengyang, , China
Research Site
Huaian, , China
Research Site
Jilin, , China
Research Site
Jining, , China
Research Site
Nanchang, , China
Research Site
Nanjing, , China
Research Site
Nanjing, , China
Research Site
Nanning, , China
Research Site
Nanning, , China
Research Site
Ningbo, , China
Research Site
Ningbo, , China
Research Site
Panjin, , China
Research Site
Pingxiang, , China
Research Site
Shanghai, , China
Research Site
Shantou, , China
Research Site
Shenzhen, , China
Research Site
Taizhou, , China
Research Site
Wenzhou, , China
Research Site
Wuhan, , China
Research Site
Wuxi, , China
Research Site
Xiamen, , China
Research Site
Xianyang, , China
Research Site
Yantai, , China
Research Site
Yibin, , China
Research Site
Zhongshan, , China
Research Site
Zhuzhou, , China
Research Site
Zigong, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D1843R00355
Identifier Type: -
Identifier Source: org_study_id