A study of dapagliflozin in Chinese adult patients with chronic kidney disease

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