Chronic Kidney Disease Registry Platform Study

Recruiting

• Conditions: Chronic Kidney Diseases

• Registration Number: NCT06117852
• Lead Sponsor: AstraZeneca

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-10-31
• Study First Submitted QC: 2023-10-31
• Study First Posted: 2023-11-07
• Study Start: 2023-11-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-14
• Primary Completion: 2027-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease Progression in CKD Patients	From 2023 to 2027	Patients with progressive deterioration of renal function, including decreased eGFR, rapid progression of CKD
Clinical Outcomes in CKD Patients - Renal Outcomes	From 2023 to 2027	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 2027	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 2027	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 2027	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 Proteinuria	From 2023 to 2027	Changes in UACR, UPCR, and 24 h urine protein (quantitative) from baseline
Estimates of Changes in Patient Conditions - Changes in eGFR	From 2023 to 2027	Changes from baseline in glomerular filtration rate (eGFR), eGFR slope

Trial Locations

Locations (1)

Research Site; 🇨🇳 Zigong, China