Clinical trial NCT06117852: Chronic Kidney Disease Registry Platform Study
Official title: Chronic Kidney Disease Registry Platform Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Diseases
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-11-07
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CKD patients with age not less than 18 years old.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disease Progression in CKD Patients
timeFrame: From 2023 to 2027
measure: Clinical Outcomes in CKD Patients - Renal Outcomes
timeFrame: From 2023 to 2027
measure: Clinical Outcomes in CKD Patients - Cardiovascular Outcomes
timeFrame: From 2023 to 2027
measure: Clinical Outcomes in CKD Patients - Cardiac and Renal Composite Outcomes
timeFrame: From 2023 to 2027
measure: Clinical Outcomes in CKD Patients - All-cause Mortality
timeFrame: From 2023 to 2027
measure: Changes in Patient Conditions - Changes in Proteinuria
timeFrame: From 2023 to 2027
measure: Estimates of Changes in Patient Conditions - Changes in eGFR
timeFrame: From 2023 to 2027
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Changchun
country: China
facility: Research Site
city: Changsha
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Chongqing
country: China
facility: Research Site
city: Dongwan
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Haikou
country: China
facility: Research Site
city: Hengyang
country: China
facility: Research Site
city: Huaian
country: China
facility: Research Site
city: Lanzhou
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Nanning
country: China
facility: Research Site
city: Ningbo
country: China
facility: Research Site
city: Panjin
country: China
facility: Research Site
city: Sanya
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shantou
country: China
facility: Research Site
city: Shenzhen
country: China
facility: Research Site
city: Taizhou
country: China
facility: Research Site
city: Wenzhou
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Wuxi
country: China
facility: Research Site
city: Xiamen
country: China
facility: Research Site
city: Xian
country: China
facility: Research Site
city: Yibin
country: China
facility: Research Site
city: Zhuzhou
country: China
facility: Research Site
city: Zigong
country: China
facility: Research Site
Study officials:
affiliation: Zhongda Hospital
name: Bicheng Liu
role: PRINCIPAL_INVESTIGATOR
References: