jRCT1071220024Not yet recruitingNot Applicable
Dapagliflozin protects eGFR decline in normoproteuric non-diabetic patients with CKD; DEFENCE trial (DEFENCE trial)
Not provided0 sites260 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 260
- Primary Endpoint
- -
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized Controlled Trial
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment Purpose
- Masking
- Open(masking Not Used)
Eligibility Criteria
- Ages
- 20age old over to 84age old under (—)
- Sex
- All
Inclusion Criteria
- •Female or male aged between 20 and 84
- •eGFR 30 or more AND less than 60 mL/min/1.73
- •Urinary protein to creatinine ratio less than 0.50g/gCr OR negative in dip stick method
- •Patients who have given written consent to participate in the study from the individual (or a surrogate)
Exclusion Criteria
- •Patients with eGFR decline within 1mL/min/1.73 per year or whose renal function has not deteriorated over the past several years and is unlikely to deteriorate in the future, as judged by investigators
- •BMI less than 20
- •Receiving therapy with a SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
- •Receiving therapy with immune suppressive drugs within 6 months prior to enrolment
- •History of renal transplantation
- •New York Heart Association(NYHA) class 4 Congestive Heart Failure at the time of enrolment
- •MI, unstable angina, stroke or transient ischemic attack(TIA) within 12 weeks prior to enrolment
- •Coronary revascularization(percutaneous coronary intervention:PCI or coronary artery bypass grafting:CABG) within 12 weeks prior to enrolment or is planned to undergo any of these procedures after randomization
- •Any condition outside the renal and cardiovascular 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 inclusion
- •Hepatic impairment(aspartate trasaminase:AST or alanine transaminase:ALT]more than 3times the upper limit of normal; or total bilirubin more than 2times upper limit of normal at the time of enrolment)
- •Women of child-bearing potential or women who have a positive pregnancy test at enrolment or women who are breast-feeding
- •Participation in another clinical study
- •Inability of the patient, in the opinion of the investigator, to understand and/or comply with investigational product.
- •In principle, employees of Kurume University School of Medicine and students of Kurume University are excluded.
Outcomes
Primary Outcomes
-
The rate of change in eGFR between 1 month and 12month after the beginning of study
Secondary Outcomes
- Composite renal outcome
Investigators
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