Study of efficacy and safety of dapagliflozin with CKD patients without diabetes and proteinuria

JRCT ID: jRCT1071220024

Registered date:05/07/2022

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Chronic kidney disease G3A1, A2
• Date of first enrollment: 05/07/2022
• Target sample size: 260
• Countries of recruitment: no,Japan
• Study type: Interventional

Intervention(s)

Group A: Dapagliflozin 10mg per day will be administered orally for 12 months.
GroupB: Current treatment will be continued for 12 months.

Outcome(s)

• Primary Outcome: The rate of change in eGFR between 1 month and 12month after the beginning of study

Secondary Outcome

1)Composite renal outcome, which is the first occurence of any of the following; the onset of end-stage kidney disease(defined as maintenance dialysis, kidney transplantation, or an estimated GFR of <15mL/min/1.73, a decline of at least 50% in the 2)estimated GFR or death from renal causes
2)Rate of newly onset of proteinuria
3)Changes of blood pressure

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 84age old
• Gender: Both

Include criteria

1)Female or male aged between 20 and 84
2)eGFR 30 or more AND less than 60 mL/min/1.73
3)Urinary protein to creatinine ratio less than 0.50g/gCr OR negative in dip stick method
4)Patients who have given written consent to participate in the study from the individual (or a surrogate)

Exclude criteria

1)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
2)Diabetes
3)BMI less than 20
4)Receiving therapy with a SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
5)Receiving therapy with immune suppressive drugs within 6 months prior to enrolment
6)History of renal transplantation
7)New York Heart Association(NYHA) class 4 Congestive Heart Failure at the time of enrolment
8)MI, unstable angina, stroke or transient ischemic attack(TIA) within 12 weeks prior to enrolment
9)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
10)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
11)Active malignancy requiring treatment at the time of inclusion
12)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)
13)Women of child-bearing potential or women who have a positive pregnancy test at enrolment or women who are breast-feeding
14)Participation in another clinical study
15)Inability of the patient, in the opinion of the investigator, to understand and/or comply with investigational product.
16)In principle, employees of Kurume University School of Medicine and students of Kurume University are excluded.

Related Information

• Primary Sponsor: Fukami Kei