Chronic Kidney Disease
Conditions
Interventions
investigational material(s)
Generic name etc : Dapagliflozin
INN of investigational material : dapagliflozin propylene glycolate hydrate
Therapeutic category code : 396 Antidiabetic agents
Dosage and
Sponsors
AstraZeneca KK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Provision of signed informed consent prior to any study specific procedures - Female or male aged 18 years or more at the time of consent - eGFR 25 or more and 75 mL/min/1.73 m2 (CKD-EPI Formula) or less at visit 1 - Evidence of increased albuminuria 3 months or more before visit 1 and UACR 200 or more and 5000 mg/g or less 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
Exclusion criteria: - Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or ANCA-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 - Type 1 diabetes mellitus - New York Heart Association (NYHA) class IV Congestive Heart Failure at the time of enrolment - MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy - | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy exploratory - | — |
Countries
Asia except Japan, Europe, Japan, North America, South America
Outcome results
None listed