A Study of Dapagliflozin in Chinese Adult Patients With Chronic Kidney Disease

This is an interventional, multicentre, Phase IV, single-arm, open-label study to investigate the efficacy and safety of dapagliflozin to prevent the progression of chronic kidney disease in Chinese adult patients.

Inclusion criteria

• Provision of signed informed consent prior to any study specific procedures
• Chinese Female or male aged ≥ 18 years at the time of consent
• eGFR ≥ 25 and ≤ 75 mL/min/1.73m2 (CKD-EPI Formula) at visit 1
• Evidence of increased albuminuria 3 months or more before visit 1 and UACR ≥ 200 and ≤ 5000 mg/g at visit 1
• Stable, and for the patient maximum tolerated labelled daily dose, treatment with ACE-I or ARB for at least 4 weeks before visit 1, if not medically contraindicated

Exclusion criteria

• Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or anti-neutrophil cytoplasmic antibodies-associated vasculitis
• Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment
• History of organ transplantation
• Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
• T1DM
• New York Heart Association class IV Congestive Heart Failure at the time of enrolment
• MI, unstable angina, stroke or TIA within 12 weeks prior to enrolment
• Coronary revascularization (PCI or CABG) or valvular repair/replacement within 12 weeks prior to enrolment
• Any condition outside the renal and CV disease area, such as but not limited to malignancy, with a life expectancy of less than 2 years based on investigator´s clinical judgement
• Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma)
• Hepatic impairment (AST or ALT > 3 × ULN; or total bilirubin > 2 × ULN at time of enrolment). An solated increase in bilirubin in patients with known Gilbert's syndrome is not a reason for exclusion
• Known blood-borne diseases
• Women of child-bearing potential (ie, those who are not chemically or surgically sterilised or who are not post-menopausal) who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator, from the time of signing the informed consent throughout the study and 4 weeks thereafter, OR women who have a positive pregnancy test at enrolment OR women who are breast-feeding
• Involvement in the planning and/or conduct of the study (applies to both AstraZeneca personnel and/or site personnel)
• Previous enrolled in the present study
• Participation in another clinical study with a study intervention during the last month prior to enrolment
• Inability of the patient, in the opinion of the investigator, to understand and/or comply with study intervention, procedures and/or follow-up OR any conditions that, in the opinion of the investigator, may render the patient unable to complete the study