Registre des maladies rénales chroniques à haut risque en Chine

Date de début de l'étude : 28 novembre 2023

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.