Dapa-CKD
- Conditions
- Chronic Kidney Disease
- Registration Number
- JPRN-jRCT2080223905
- Lead Sponsor
- AstraZeneca KK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 240
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>-
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>exploratory<br>-