Chronic Kidney Disease Registry Platform Study

Chronic Kidney Diseases Clinical Trial

Official title:

Chronic Kidney Disease Registry Platform Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06117852
• Other study ID #: D1843R00355
• Status: Recruiting
• Start date: November 28, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Exclusion Criteria:

1. Patients who have previously undergone/are undergoing/are planning to undergo solid organ transplantation;

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.

Group A (Participants with CKD and High Proteinuria) Inclusion & Exclusion Criteria:

Inclusion criteria:

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.

Exclusion criteria:

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.

Group B (patients with CKD and Hypertension) Inclusion & Exclusion Criteria:

Inclusion criteria:

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:

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	Research Site	Beijing
China	Research Site	Beijing
China	Research Site	Changchun
China	Research Site	Changsha
China	Research Site	Chengdu
China	Research Site	Chongqing
China	Research Site	Dongwan
China	Research Site	Guangzhou
China	Research Site	Guangzhou
China	Research Site	Hengyang
China	Research Site	Huaian
China	Research Site	Lanzhou
China	Research Site	Nanjing
China	Research Site	Nanjing
China	Research Site	Nanning
China	Research Site	Ningbo
China	Research Site	Panjin
China	Research Site	Sanya
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	Xian
China	Research Site	Yibin
China	Research Site	Zhuzhou
China	Research Site	Zigong

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Progression in CKD Patients	Patients with progressive deterioration of renal function, including decreased eGFR, rapid progression of CKD	From 2023 to 2026
Primary	Clinical Outcomes in CKD Patients - Renal Outcomes	Including renal transplantation, maintenance dialysis, death from renal failure, persistent low eGFR, persistent percent decline in eGFR	From 2023 to 2026
Primary	Clinical Outcomes in CKD Patients - Cardiovascular Outcomes	Including acute myocardial infarction, sudden serious arrhythmia, hospitalization due to heart failure, stroke or apoplexy, cardiovascular death	From 2023 to 2026
Primary	Clinical Outcomes in CKD Patients - Cardiac and Renal Composite Outcomes	Composite outcome measure consisting of multiple single outcome measures for cardiovascular outcomes and renal outcomes	From 2023 to 2026
Primary	Clinical Outcomes in CKD Patients - All-cause Mortality	In-hospital or out-of-hospital deaths from all causes, including but not limited to deaths related to cardiovascular outcomes or renal outcomes, etc.	From 2023 to 2026
Primary	Changes in Patient Conditions - Changes in Proteinuria	Changes in UACR, UPCR, and 24 h urine protein (quantitative) from baseline	From 2023 to 2026
Primary	Estimates of Changes in Patient Conditions - Changes in eGFR	Changes from baseline in glomerular filtration rate (eGFR), eGFR slope	From 2023 to 2026