a study of dapagliflozin in chinese adult patients with chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: the purpose of this study is to describe the efficacy and safety information with dapagliflozin in chinese 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.

Eligibility criteria:
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