Dapagliflozin and Renal Surrogate Outcomes in Advanced Chronic Kidney Disease

Prior treatment

• Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor.

Other illness

• Any condition outside the renal and CV disease area, 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.
• Frequent urosepsis (≥2 times in one year before enrollment) and history of Fournier's gangrene.
• Inability of the patient, in the opinion of the investigator, to understand and/or comply with treatment, procedures and/or follow-up OR any conditions that, in the opinion of the investigator, may render the patient unable to complete the study.

Lab values

• Lupus nephritis, anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis and organ transplantation.

Other

• Women of child-bearing potential who are not willing to use a medically accepted method of contraception throughout the study, OR women who have a positive pregnancy test at enrolment OR women who are breast-feeding.
• Urinary tract obstruction (hydronephrosis, hydroureter and abnormal post-voiding residual urine volume under renal echography).

• Provision of informed consent prior to any study specific procedures.
• Aged ≥20 years at the time of consent.
• eGFR ≥10 and ≤30 mL/min/1.73m2 (Modification of Diet in Renal Disease (MDRD) equation ) at randomization.
• eGFR decline ≥2.5 mL/min/1.73m2 (≥ 3 measurements, simple linear regression) in one year before randomization.
• In the pre-ESRD care and education program of Ministry of Health and Welfare of Taiwan (pre-ESRD program) for ≥3 months before randomization.