Chronic Kidney Disease Registry Platform Study

Launched by ASTRAZENECA · Oct 31, 2023

Keywords

ClinConnect Summary

The Chronic Kidney Disease Registry Platform Study is a research project aimed at better understanding chronic kidney disease (CKD). This study will collect important information about patients with CKD, including their age, causes of the disease, clinical characteristics, and how they are diagnosed and treated. By doing this, researchers hope to find gaps in current treatment guidelines, identify risk factors that could lead to disease progression, and develop a model to predict future health outcomes for CKD patients.

To participate in this study, you must be at least 18 years old and meet certain criteria related to CKD diagnosis and kidney function. For example, your kidney function (measured by a test called eGFR) must fall between specific values. If you have conditions like heart failure, severe liver injury, or are undergoing certain treatments, you may not be eligible. Participants will provide data through questionnaires and medical records and will help contribute to a larger understanding of CKD, which may lead to improved care for future patients. Your involvement is voluntary, and you will need to sign a consent form to participate.

Gender

ALL

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.